Government of Pakistan

Ministry of National Health Services, Regulation & Coordination

Drug Regulatory Authority of Pakistan
***********
MINUTES OF THE 12TH MEETING OF THE MEDICAL DEVICE BOARD (MDB)
HELD ON 13-05-2019

12th meeting of the Medical Device Board (MDB) was held in the office of Drug Regulatory
Authority of Pakistan, TF Complex, G-9/4, Islamabad on 13 th May, 2019. The Secretary MDB referred to
Sub-rule (9) Rule (59) of Medical Devices Rules, 2017 where in the absence of Chairman MDB members
may elect one of the members to preside over the meeting. The members unanimously elected Dr. Prof.
Saqib Shafi Sheikh, member MDB to preside over the meeting as Chairman. Subsequently meeting was
chaired by Dr. Prof. Saqib Shafi Sheikh, Interventional Cardiologist, Mayo Hospital, Lahore and was
attended by the following:-
S.No. Name and Designation / Department Position in the
MDB
1. Dr. Prof. Saqib Shafi Sheikh, Interventional Cardiologist, Member /
Mayo Hospital, Lahore. Chairman

2. Dr. Abdul Haleem Khan, Associate Professor & Member

Chairperson, Department of Pharmacy, Forman Christian
College, Lahore.

3. Mr. Muhammad Alamgir Rao, Director Procurement, Member

Director General Health Services, Lahore. (Nominee of
Director General Health, Punjab).

4. Mr. Imranullah, Chief Drug Inspector, Abbottabad, KPK, Member

(Nominee of Director General Health, Khyber
Pukhtunkhwa).

5. Dr. Prof. Sajid Bashir, Professor of Pharmaceutics, Member

University of Sargodha, Sargodha.

6. Brig. ® Dr. Waqar Azim Niaz, Consultant Urologist & Member

Transplant Surgeon, Quaid-e-Azam International
Hospital, Islamabad.

7. Mr. Muhammad Asghar, CEO, Cyber Soft Technologies, Member

Lahore.

8. Mrs. Tazeen S. Bukhari, Biomedical Equipment Planner, Member

Saleem Memorial Trust Hospital, Lahore.

9. Dr. Ghazanfar Ali Khan, Additional Director (MDMC), Secretary /

DRAP, Islamabad. Member

1
 The meeting started with the recitation of the Holy Quran. The Secretary MDB welcomed all the

participants and presented the agenda of the meeting.

Item No.I. CONFIRMATION OF MINUTES OF 11TH MEDICAL DEVICE BOARD

MEETING.

Decision: The Board confirmed the minutes of the 11th meeting of MDB.

Item No. II. APPLICATIONS FOR GRANT OF ESTABLISHMENT LICENSE TO IMPORT MEDICAL
DEVICES.

The following firms have applied for grant of Establishment License to import medical

devices under MDR, 2017 for which inspection panels were constituted for inspection of their

establishments. The recommendations of the panels areas mentioned against each is submitted for

consideration of MDB please:-

Decision:- The MDB decided as mentioned against each:-

2
 Sr. Name of Director/ Name of Cold Decisions
No. Establishment Proprietor / Panel of Chain
Partners Inspector(s) (Yes/No
)
1. M/s Dolitso Pakistan Mr Habib Ms. Hira No Approved for storage of
Pvt Ltd. Suit No 3, Ahmed Bhutto, AD-I room temperature
Building 13C, 5th Navaid (MD&MC), medical devices without
commercial Lane, DRAP, cold chain facility.
Islamabad.
Sehar commercial Mrs. Iffat
Area, DHA Phase 7, Fatima
Hafiz
Karachi. Navaid Muhammad
Godown address: Asif Iqbal,
Same as above AD-V
(MD&MC),
DRAP,
Islamabad
2. M/s Hakimsons Pvt Nawazish -do- No Approved for storage of
ltd.A-58/B, SITE, Ali Hakim. warm range (above 30°C)
Mangophir Road, medical devices without
Karachi. Nayyar cold chain facility.
Jahan
Godown address: Hakim.
Same as above
Naveed
Hakim.

3. M/s Marie Stopes Ms. Asma -do- No Approved for storage of

Society, 21 C- Balal room temperature
Commercial Area, medical devices without
Old Sunset Muhammad cold chain facility subject
Boulevard, DHA Shaiq to provision of DSL
Phase 2, Karachi. Usmani

Godown address: Ronaq Iqbal

P.No.B-93, Sector 31- Lakhani
A, Korangi Township
K.I.A, Karachi. Arjumand
Ahmed
Minai

3
4. M/s Creative Jawaid -do- No Approved for warm
Network Solution., Hussain. range (above 30°C)
G-170, G-199 Naz medical devices with
Plaza M.A Jinnah limited storage without
Road, Karachi. cold chain facility.

Godown address:
Same as above

5. M/s V-Care Abdul -do- No. Approved for storage of

International, Hameed room temperature
Maznine Floor, Flat Khan medical devices without
No 02, Plot No 8-C, cold chain facility.
6th Sunset Sikandar
Commercial Lane, Khan
24th Commercial
Street, Phase II,
Extension DHA,
Karachi.

Godown address:
Plot No. 23, D/1,
Khayaban-e-Jami,
Phase-II Extension
DHA, Karachi.

6. M/s Analytical Zahid -do- Yes Approved for storage of

Measuring System Mustafa cold chain and warm
(Pvt) Ltd, AMS range (above 30°C)
House 14-C, Main Syed Saad medical devices.
Sehar Commercial Mustafa
Avenue, Lane No 4,
Khayaban e Sehar,
DHA Phase VII,
Karachi.

Godown address:
Same as above

7. M/s Sapphire Muhammad -do- No Approved for storage of

International, Room Nadeem warm range (above 30°C)
No 903, 9th Floor Malik medical devices without
Uni Center, I.I. cold chain facility.
Chundrigar Road
Karachi.

4
 Godown address:
Same as above

8. M/s Bench Mark Faraz -do- No Approved for storage of

Corporation, A-706, Ahmed room temperature
7th Floor, Saima medical devices without
Trade Tower, I.I cold chain facility.
Chundrigar Road,
Karachi.
Godown address:
M-12, Mezzanine
Floor, Saima Trade
Tower,
I.I.Chundrigar Road,
Karachi.

9. M/s Mehran Dental Dhanraj -do- No Approved for storage of

Supplies, Assnani room temperature
medical devices without
Headoffice:
cold chain facility.
Office No. 207 SF14,
2nd Floor , Apwa
Complex opposite
IBA & AMP. Ankle
Saria Hospital
Karachi.
Godown:
F-12, 2nd Floor, Apwa
Complex Opp. Ankle
Saria Hospital,
Karachi.

10. M/s S.S. Surgical Sardar -do- No Approved for storage of

Point, Building No Humayun room temperature
111-C, Mezzanine Rizwan. medical devices without
Floor, Phase II Ext cold chain facility.
DHA, Karachi. Shahan
Humayun.
Godown address:
Same as above.

11. M/s Organs Pharma, Saif Ur -do- No Approved for storage of

Office No 2, 2nd Rehman. room temperature
Floor Plot No. 50-D medical devices without
Khyaban e Ittehad Atiq Ur cold chain facility.
5
 Muslim Commercial, Rehman
Phase VI, DHA,
Karachi. Kashif
Rehman
Godown address:
Same as above
12. M/s Galaxy Pharma Kashif -do- Yes Approved for storage of
(Pvt) Ltd., D-180, Rehman cold chain and room
Rojhan Street, Block temperature medical
5, Clifton Karachi. devices.
Godown address:
Same as above

13. M/s CSM Pakistan Amos -do- No Approved for storage of

(Gurantee) Ltd.,23- Nadeem. room temperature
C/ Commercial medical devices without
Area,Old Sunset Mohsina cold chain facility.
Boulevard, DHA Ahsan
Phase 2, Karachi Bilgrami

Godown address: Naheed

P.No.C-21, Sector 31- Khuhro
A, Mehran
Extension, Korangi
Industrial Area,
Karachi.
14. M/s Bios, Building Munir -do- No Approved for storage of
2C, 12 Commercial Ahmed warm range (above 30°C)
Phase II Ext DHA, medical devices without
Karachi. cold chain facility.
Godown address:
Same as above.
15. M/s IHI Integrated Khalid -do- Rejected due to
Human Initiatives, Qureshi outsource storage facility.
Elaaf Center 1, First
Floor, C-5/C-1, Lane-
3, Khyaban e Nishat,
Phase 6
DHA,Karachi.

16. M/s Kaf Surgical & Kausar -do- No Approved for storage of
Disposable Parveen warm range (above 30°C)
Equipment, Shop No medical devices without
20, Medicine Corner, cold chain facility.
Mezzanine Floor,

6
 Medicine Market
Denso Hall, Karachi.

Godown address:
Shop No.10, 3rd Floor,
Medicine Corner,
Medicine Market,
Denso Hall, Karachi.
17. M/s Kingston Health Arshad -do- No Approved for storage of
Crafts (Pvt) Ltd, warm range (above 30°C)
Nawab
Mezzanine Floor medical devices without
Building No 5C, Lane cold chain facility.
No 10, Commercial
Omar
Area, Khayaban- e-
Sehar Phase 7, Nawab
DHA,Karachi.

Godown address:
Same as above.
18. M/s Bayer Pakistan Imran -do- No Approved for limited
(Pvt) Ltd C-21, SITE, Ahmad stoarage facility for
Karachi. Khan medical devices without
cold chain fcility.
Muhammad
shafiq
19. M/s Elegant Health Sahibzada -do- No Approved for storage of
Services, Suit No.123- Adeel warm range (above 30°C)
124, 1st Floor, SP Ahmed medical devices without
Chamber, SITE, cold chain facility.
Karachi.

Godown address:
House NO.80,
Mussarrat Colony,
Near Rehmania
Masjid, Nazimabad
No.1, Karachi.

20. M/s Zam Zam Muhammad -do- No Approved for storage of

Corporation, Suit Iqbal. room temperature
No.205-206, 2nd Floor, medical devices without
6-CL-10 Beaumont cold chain facility.
Plaza, Beaumont
Road, Karachi.
Godown address:
Suit No.10, Ground
7
 Floor, 6-CL-10
Beaumont Plaza,
Beaumont Road,
Karachi.
21. M/s Lab Line, 98, Jahnagir -do- Yes Approved for storage of
National Medicine cold chain medical
Chishty
Market, Arambagh devices.
Road, Karachi.
Godown address:
Same as above.

22. M/s Bio Medical Joaquim -do- No Approved for storage of

Technologies, 407, 4th warm range (above 30°C)
Alvares
Floor Madina City medical devices without
Mall, Abdullah cold chain facility.
Haroon Road,
Karachi.

Godown address:
408, 4th Floor Madina
City Mall, Abdullah
Haroon Road,
Karachi.

23. M/s Melamine Abdul -do- No Approved for storage of

Emporium, 814, Star Munim Akif room temperature
City Mall, Saddar, medical devices without
Karachi. cold chain facility.

Godown address:
Same as above.

24. M/s Technology Zubair -do- No Approved for storage of

Links (Pvt) Ltd, 4/18 warm range (above 30°C)
Farooqui
Rimpa Plaza, 4th medical devices without
Floor, M.A Jinah cold chain facility.
Road, Karachi.

Godown address:
Room No.4/4, Rimpa
Plaza, 4th Floor, M.A
Jinah Road, Karachi.

25. M/s SK Surgical, 60 Muhammad -do- No Approved for storage of

C, Mezzanine Floor, Kaleem room temperature
11th Commercial medical devices without
8
 Street, DHA Phase-II, cold chain facility.
Karachi.

Godown address:
Same as above.
26. M/s Sy,AH Impex Syed Omer Mr. No Approved for storage of
Head Office: Ahmed Muhammad room temperature
1-6/15 Sector 5, Ayub Naveed, medical devices without
Korangi Industrial AD-II cold chain facility.
(MD&MC),
Area, Karachi.
DRAP,
Godown address:
Islamabad.
Same as above
Mrs. Unum
Zia Shamsi,
AD-IV
(MD&MC),
DRAP,
Islamabad.

27. M/s Diabetapak Mr. Shakaib -do- No Approved for storage of

(Pvt) Ltd Ahmed room temperature
Head Office: Qureshi medical devices without
Showroom No 3 cold chain facility.
Ground Floor, Farah
Dadabhoy Centre, Mumtaz
Plot ST-11 Shahrah-
e- Faisal Karachi.
Godown address:
Same as above
28. M/s Battla Brothers Naseem -do- No Approved for storage of
Head Office: Akhtar Battla room temperature
Shop No:12 H.J medical devices without
Centre, Kutchi Gali cold chain facility.
No 2. Marriot Road
Karachi.
Godown address:
C/16, 3rd floor H.J
Centre, Kutchi Gali
No 2. Marriot Road
Karachi.

29. M/s Biomadics Baqi Bullah -do- Yes Approved for storage of
Head Office: temperature sensitive and
No 4, Ground Floor, room temperature
Happy Heights, (limited capacity) medical
Modern Housing devices.
Society, Shaheed-e-
9
 Millat Road, Karachi.
Godown address: No
5, Ground Floor,
Happy Heights,
Modern Housing
Society, Shaheed-e-
Millat Road, Karachi.
30. M/s Euronano Alper -do- Yes Approved for storage of
Diagnostics (Pvt) Ltd Akyuz. temperature sensitive and
Head Office: room temperature
Plot No 225/1/F, Elif Akyuz (limited capacity) medical
Block-2, PECHS devices subjecdt to
Society, Jamshed Abdullah provision of DSL.
Town, Karachi. Abdul
Godown address: Waheed
Same as above

31. M/s Sanoptech Amar -do- No Approved for storage of

Head Office: Furquan Butt room temperature
Second Floor, D-22, medical devices without
Block D, North cold chain facility.
Nazimabad, Karachi.
Godown
address:First Floor,
D-22, Block D, North
Nazimabad, Karachi.

32. M/s Samerian's Muhammad -do- No Approved for storage of

Enterprises Hanif room temperature
Head Office: Soomro medical devices without
Shop No 4, First cold chain facility.
Floor, H.J Centre,
Kutchi Gali No.2,
Marriot Road,
Karachi.
Godown address:
Suite # 1, Ground
Floor, Cambel Street,
SR-7, Shahrah-e-
Liaquat, Karachi
33. M/s Ameer Din Salman-Ul- -do- No Approved for storage of
Instruments Arshad warm range (above 30°C)
Head Office: medical devices without
Office No 1, Mono Fasih Ud Din cold chain facility.
Garden 3, N.K.C.H.S,
Shaheed-e-Millat
Road, Karachi.
10
 Godown address:
Office No 5, Mono
Garden 3, N.K.C.H.S,
Shaheed-e-Millat
Road, Karachi.
34. M/s Rehman Abdul -do- No Approved for storage of
Medicine Co. Head Rehman room temperature
Office: Soomro medical devices without
Shop No. 1 & 2, First cold chain facility.
Floor, H.J Centre,
Kutchi Gali No.2,
Karachi

Godown
address:Suite # 2,
Ground Floor,
Cambel Street, SR-7,
Shahrah-e-Liaquat,
Karachi

35. M/s K.S Agencies Muhammad -do- No Approved for storage of

Head Office: Idrees room temperature
Office No, 210, Memon medical devices without
Business Arcade, cold chain facility.
Main University
Road, Karachi.

Godown address:
33 & 34 Business
Arcade, Main
University Road,
Karachi.

36. M/s Unique Visual Muhammad -do- No Approved for storage of

System Javed Jabbar room temperature
Head Office: medical devices without
L-18, Block-17, Muhammad cold chain facility.
Gulshan-e-Iqbal Raees
Karachi
Godown address: Abdul
Same as above Samad

37. M/s Hospital Supply Mehtabuddi -do- Yes Approved for storage of
Corporation n Feroz. temperature sensitive and
Head Office: room temperature
42 Darul Aman Muhammad medical devices.
Housing Society, Yahya
11
 Block 7 & 8, Karachi. Feroz
Godown address:
Same as above Sohail Feroz.
(Inspection for
inclusion of cold
chain and room
temperature medical
devices storage
facility in ELI-
00005).

38. M/s Martin Dow Mr Amjad -do- Yes Approved for storage of
Marker Specialities room temperature
(Pvt) Ltd. Ali Amir medical devices. Cold
Head Office: chain facility already
D-7 Shaheed-e-Millat Anis Ahmad approved.
Road, Karachi. Shah.
Godown address:
Plot No.130, Sector
15,
Korangi Industrial
Area, Karachi.
(Inspection for
inclusion of room
temperature medical
devices storage
facility in ELI-
00160).

39. M/s Jasani Arshad Ali -do- No Approved for storage of

Scientifics, Jasani room temperature
Head Office: Office medical devices without
No. 1, SC-45, Marium cold chain facility.
Square Chandni
Chowk Stadium
Road, Karachi.
Godown Address:
1. Shop No.2, C-A-34,
Karim Palace,
Chandni Chowk,
Stadium Road,
Karachi.
2. Office No. 2, SC-
45, Marium Square
Chandni Chowk
Stadium Road,
Karachi.

12
40. M/s Burraq Muhammad -do- No Approved for storage of
Enterprises Tufail room temperature
Head Office: Khanzada medical devices without
Kishwer House 1/7- cold chain facility.
B, 2nd Floor,
Muhammad Ali
Cooperative Housing
Society, Karachi.

Godown Address:
C2, Block N, North
Nazimabad, Karachi.

41. M./s Green Top Ghulam -do- No Approved for storage of

Pharma, Head Office: Akbar room temperature
B-137, Block-D, Five medical devices without
Star Chowrangi, cold chain facility.
North Nazimabad,
Karachi.

Godown Address:
Plot No.E-415, Metro
Cinema, Orangi
Town, Karachi.

42. M/s Kantech Anwer Baig -do- No Approved for storage of

Medical System room temperature
Head Office: medical devices without
Office No. R-820 cold chain facility.
Ground Floor, Block-
1, Federal B Area,
Opposite Delhi
College, Karachi.

Godown Address:
Same as above

43. M/s Combined Muhammad -do- No Approved for storage of

Engineers Altash Butt room temperature
Head Office: medical devices without
H.No.246, St. No.17, Choudhry cold chain facility.
BMCHS, Sharfabad, Muhammad
Karachi. Nadeem
Godown Address:
Same as above Muhammad
Saleem

13
 Anwar
44. M/s Dentsco Zesheen -do- No Approved for storage of
International room temperature
idrees Daar
Head Office: (limited capacity) medical
Suit No M-14 Dada Nauman devices without cold
Terrace, Main chain facility.
Idrees Dar
Shaheed-e-Millat
Road, Karachi.
Godown Address:
Suit No M-15 Dada
Terrace, Main
Shaheed-e-Millat
Road, Karachi.

45. M/s Ethos Saeed -do- No Approved for storage of

Healthcare (Pvt) Ltd Rasheed room temperature
Head Office: medical devices without
1st Floor, Plot No 18, Muhammad cold chain facility.
Sector 47, Survey 86, Ali Saya
Off main Korangi
Creek Road, Karachi.
Godown Address:
Same as above
46. M/s Ruella Medical, Kamran -do- No Approved for storage of
Muhammad room temperature
Head Office:
Khan (limited capacity) medical
Suit No 1002, 10th
devices without cold
Floor, Kawish Crown
chain facility.
Plaza, Shahra-e-
Faisal,Karachi.
Godown address:
same as above.

47. M/s Lucky Lab Muhammad -do- Yes Approved for storage of
International Jawad temperature sensitive and
Head Office: Akhter room temperature
F-6 Usmania Center, medical devices.
Muhammad Ali
Housing Society,
Commercial Market,
Karachi.
Godown
address:same as
above
48. M/s M.N. Enterprise, Abdul -do- No Approved for storage of
Head Office: Wahab room temperature
Plot No 65/3, B.Y. medical devices without

14
 J.C.H.S., Near Portia cold chain facility.
Fabric, Bahadurabad,
Karachi.
Godown
address:same as
above

49. M/s Mydent Sohail -do- No Approved for storage of

International Rasheed room temperature
Head Office: medical devices without
A-16, 4th Floor, Block cold chain facility.
13-C, Dashtiyaar
Chambers, SB 32,
Gulshan-e-Iqbal,
Karachi.
Godown
address:same as
above

50. M/s United Brothers Khalid -do- No Approved for storage of

Head Office: Rashid room temperature
Office No 301, medical devices without
Mehrab Market cold chain facility.
Medicine Street No 1,
Marriot Road,
Karachi.

Godown
address:Plot No SA:
05-06, Sector 31-B,
Shah Muhammad
Road, Korangi
Industrial Area,
Karachi
51. M/s Medi Impex Shahzad -do- No Approved for storage of
Head Office: Malik room temperature
Room No 109 medical devices without
Rehmani Chamber, Farrukh cold chain facility.
Altaf Hussain Road, Naseem
New Challi Karachi.

Godown
address:Room No
103 Rehmani

15
 Chamber, Altaf
Hussain Road, New
Challi Karachi.
52. M/s Surgical World Fahad Anis -do- No Approved for storage of
Head Office: room temperature
Office No 105, 1st medical devices without
Floor, Rehmani cold chain facility.
Chambers, Altaf
Hussain Road New
Challi, Karachi.
Godown
address:Office No
104, 1st Floor,
Rehmani Chambers,
Altaf Hussain Road
New Challi, Karachi.

53. M/s Biotech Pakistan Kashif Latif -do- No Approved for storage of
Head Office: room temperature
Suit No. 302 & 303, medical devices without
3rd Floor, cold chain facility.
Tahir Plaza, KCHS.,
Shahrah-e-Faisal,
Karachi.
Godown address:
H.No 3626, TP II,
Street III,
Mehmoodabad,
Karachi

54. M/s Leven Medical Adeel Ur Ms. Hira No Approved for storage of
Care Rehman Bhutto, AD- room temperature
Head Office: I (MD&MC), medical devices without
8-C Ground Floor, St DRAP, cold chain facility.
Islamabad.
No. 3, Shah Jamal,
Lahore.
Mrs. Unum
Godown address:
Zia Shamsi,
Same as above
AD-IV
(MD&MC),
DRAP,
Islamabad
55. M/s Pharm Canada Asadullah -do- No Approved for storage of
Pakistan Khan room temperature
Head Office: medical devices without
391 -B, Faisal Town, Assad cold chain facility.
Lahore. Godown Maqbool

16
 address:
Same as above
56. M/s Forcare Shaikh -do- No Approved for storage of
Head Office: Naeem room temperature
788, Block J-2 M.A, Ahmad medical devices without
Johar Town Lahore. cold chain facility subject
Godown address: Shoukat Ali to provision of DSL.
Same as above
Talat
Mehmood
Qureshi.
57. M/s 3N- Lifemed Nazir -do- No Approved for storage of
Head Office: Ahmad room temperature
18/20N, Gulberg-II, medical devices without
Lahore. cold chain facility.
Godown address:
Same as above
58. M/s Basic Jaleel ur -do- Yes Approved for storage of
Pharmaceuticals Rehman temperature sensitive and
(Pvt) Ltd (CEO) room temperature
Head Office: medical devices
14-A, Babar Block, Rafiq-ur-
New Garden Town Rehman
Lahore.
Godown address:
Same as above
59. M/s Martin Dow Mr Amjad -do- Yes Approved for inclusion
Marker Specialties of Warehouse in existing
(Pvt) Ltd. Ali Amir ELI-00160 for storage of
Head Office: temperature sensitive and
D-7 Shaheed-e-Millat Anis Ahmad room temperature
Road, Karachi. Shah. medical devices.
Godown Address:
75/1-M, Quaid-e-
Azam Industrial
Estate, Township Kot
Lakhpat Lahore.
(For inclusion of
Warehouse in ELI-
00160).

60. M/s Accu Sight Mr. Zaigham -do- No Approved for storage of
Head Office: Mansoor room temperature
131, Nasheman e Khan medical devices without
Iqbal Housing cold chain facility.
Society Phase 1,
17
 Jinnah Avenue
Lahore.
Godown Address:
Same as above

61. M/s McPharm Azhar -do- No Approved for storage of

International (Pvt) Farooq room temperature
Ltd medical devices without
Head Office: Tahir Imtiaz cold chain facility.
219-A Lalazar
Commercial Market, Aasim
Raiwind Road Farooq
Lahore.
Godown Address:
Same as above

62. M/s Votex Pharma Aasim -do- No Approved for storage of

(Pvt) Ltd Shahzad room temperature
Head Office: medical devices without
60-A, Faisal Town Shala Aasim cold chain facility.
Lahore. (CEO)
Godown Address:
Same as above

63. M/s Al Waali Care Abdul -do- No Approved for storage of

Concepts Waheed. room temperature
Head Office: medical devices without
86-Allama Iqbal Abu Baker cold chain facility.
Road, Chah Baba Siddique.
Shadiwal Street,
Garhi Shahu, District
Lahore.
Godown Address:
Same as above

64. M/s Jet Services Muhammad -do- No Approved for storage of

International, Anas Ali room temperature
Head Office: Kasuri. medical devices without
231- Block B2, Johar cold chain facility.
Town Lahore. Syed Imran
Godown Address: Arif
Same as above
Kalim Shuja

65. M/s Muslim Sami Ullah -do- No Approved for storage of

Scientific Sheikh room temperature
Corporation medical devices without

18
 Head Office: cold chain facility.
3-Syed Moj Darya
Road, Lahore.
Godown Address:
57-B, PAF Colony,
Zarar Shaheed Road,
Lahore Cantt, Lahore

66. M/s Forward Asim -do- No Approved for storage of

Solutions Mahmood room temperature
Head Office: Khan medical devices without
Plot No 19-B cold chain facility.
Qazalbash Chowk, Sajid Ali
Abdul Sattar Edhi Khan
Road Distt, Lahore.
Godown Address: Muhammad
Same as above Naeem
Khalid
67. M/s KASBN Babar -do- No Approved for storage of
International Waseem room temperature
Head Office: Kayani medical devices without
422-A-1, Ghalib cold chain facility.
Market, Gulberg-III,
Lahore.
Godown Address:
Same as above

68. M/s Remington Abdul -do- Yes Approved for storage of

Pharmaceutical Qadeer temperature sensitive and
Industries (Pvt) Ltd., Khokhar room temperature
Head Office: medical devices.
18 Km Multan Road, Shaheena
Lahore. Qadeer
Godown Address: Khokhar
Same as above
Faisal
Qadeer
Khokhar

Shahab
Qadeer
Khokhar
69. M/s Lens House Muhammad -do- No Approved for storage of
Head Office: Shahid room temperature
3rd Floor, Musarat Alam. medical devices without
Plaza, Ainak Market, cold chain facility.
Shah Alam Market, Mrs.Aqsa

19
 Lahore. Shahid.
Godown Address:
Same as above

70. M/s Technoware Azhar -do- No Approved for storage of

Head Office: Mehmood room temperature
PS-65, 2nd floor, UBL Khan medical devices without
Bank, Al-Jannat cold chain facility subject
Building, Robert to provision of DSL.
Road, Nila Gumbad,
Lahore
Godown Address:
Same as above

71. M/s Heartec Saima Fazal -do- No Approved for storage of

Head Office: room temperature
1st Floor, 734, medical devices without
Shadman 1, inside cold chain facility.
Alam Audiology
Clinic, District
Lahore.
Godown Address:
Same as above

72. M/s Ahmad Medix Dr. Sohail -do- No Approved for storage of
Pvt Ltd Mukhtar room temperature
Head Office: Ahmad medical devices without
129/6 Quaid-e- cold chain facility.
Azam Industrial Mrs.Kausar
Estate, Township, Sohail
Lahore.
Godown Address: Mr. Adeel
Same as above Ahmad

73. M/s HSB Innovation Sarfaraz Ali -do- No Approved for storage of
in Health Shah room temperature
Head Office: medical devices without
Suite No C-3A, Third cold chain facility.
Floor, First City
Tower, More
Samanabad, Lahore.
Godown Address:
Same as above

74. M/s Surgi Vision, Babar Abbas -do- No Approved for storage of
Head Office: room temperature
Plot No.7-A, Model medical devices without

20
 Town, Lahore. cold chain facility.
Godown Address:
Same as above
75. M/s Medilink Rana Amjad -do- No Approved for storage of
Trading And Hanif room temperature
Maintenance (Pvt) medical devices without
Ltd Mrs Nadia cold chain facility.
Head Office: Amjad
654-D Canal View,
Distt Lahore.
Godown Address:
Same as above

76. M/s Womas Shees Haider Mr. No Approved for storage of

International, Saadat Zaidi Muhammad room temperature
House, Aqsa Street, Ayub Naveed, medical devices without
Capital Road, Nia AD-II cold chain facility.
(MD&MC),
Miana Pura, Sialkot.
DRAP,
Islamabad.

Hafiz
Muhammad
Asif Iqbal,
AD-V
(MD&MC),
DRAP,
Islamabad.
77. Mian Scientific Muhammad -do- Yes Approved for storage of
Corporation Pvt Ltd., Tahir cold chain and room
Office No. 534, Yaqooq. temperature medical
Jinnah Colony devices.
Faisalabad. Muhammad
Godown Address: Abid Yaqoob
273 Rehman Garden,
Near City Housing ,
Chak No.5/J-B,
Kamal Pur, Sargodha
Road, Faisalabad.

78. M/s Shams Scientific Irfan Ayaz -do- Yes Approved for storage of
Traders, Office No 7, cold chain and room
First Floor Sadiq temperature medical
Plaza, P-481-Jinnah devices.
Colony, Faisalabad.
Godown Address:
22-Y-J, Madina
Tower,Faisalabad
21
79. M/s Dia Scient Muhammad -do- Yes Approved for storage of
International, Room Ehsan cold chain and room
No.11, 12, 13, 14, temperature medical
Emaan Arcade, Iqbal devices.
Stadium Road New
Civil Line Faisalabad.

80. M/s Novatek Munawwar -do- No Approved for storage of

Pakistan, P-20, 1st Hussain room temperature
Floor, Office No.1, Zahid medical devices without
Channab Market, cold chain facility.
Susan Road, Madina
Town, Faisalabad.

81. M/s Shaheer Pharma Rana Khalid -do- No Approved for storage of
Enterprises, House Ghaffar room temperature
No. 443/2, Bahar medical devices without
Shah Zafar Road, cold chain facility.
Near Chema Heart
Center, Sargodha.

Godown Address:
Same as above.

82. M/s Mukhtar A. Mr. Faisal -do- No Rejected. Establishment

Sheikh Memorial Ahmad Licence to Import (ELI)
Welfere Hospital- Mukhtar medical devices are for
Workwers Welfare commercial imports.
Board, Jahangirabad, Mrs Atifa Since hospitals are
Near Pakarab Riffat exempted from Sales Tax
Fertilizers Limited, and Customs Duty,
Main Khanewal Mr. therefore, misuse
Road, Multan. Muhammad potential exists where a
Qasim hospital may import
Godown Address: Samad Khan medical devices under
Same as above. ELI and sale it
Mr. commercially. The
Muhammad provision for import of
Bilal medical devices for
hospitals are given under
Rehman Rule 24 of Medical Device
Naseem Rules, 2017.

Mukhtar
Ahmad
Khan

22
 Qamoos Gul
Khattak

Maqbool
Khan

Zaheer Khan

Mr. Amir
Shahnshah
Athar
83. M/s Abdullah Fayyaz Ali -do- Yes Approved for storage of
Traders, 3 Green cold chain and room
Town, Ghous-ul- temperature medical
Azam Road, Multan. devices.
Godown Address:
Same as above.

84. M/s Nimra Farma, Sabir Sohail -do- No Approved for storage of
223/4, Abdul Habib Mir room temperature
Khan Road, medical devices without
Tariqabad, Babar Mir cold chain facility.
Rawalpindi

85. M/s Cabbot Muhammad -do- No Approved for storage of

Surgicals, Ho No CB Attique room temperature
6060 Rose Lane 3-A Shahid medical devices without
New Lalazar cold chain facility.
Rawalpindi

86. M/s Amir Muhammad -do- No Approved for storage of

Enterprises, 1st Floor Asim Khan room temperature
Plaza No 55, Opp. medical devices without
Security Chekpoint cold chain facility.
Gate No 1, Gulshan
Abad, Adyala Road,
Rawalpindi.

87. M/s Cent Dix Syed -do- No Approved for storage of

Curative Smc-Pvt ltd, room temperature
Muhammad
Office No 201-03, 2nd medical devices without
Floor, Platinum Zeeshan cold chain facility.
Arcade, 11/1 Civic
Haidar
North Commercial,
Soan Garden,
Islamabad.

23
88. M/s Life Elements Muhammad -do- No Approved for storage of
Pvt Ltd, Office No 5 Irfan Azam room temperature
Ground Floor, medical devices without
Nawab Plaza, Shazia Irfan cold chain facility.
Shallay Valley,
Range Road,
Rawalpindi.

89. M/s Swera Phama Iftikhar -do- No Approved for storage of

Distributers, House Ahmed room temperature
No 687, Street No 3, medical devices without
Ch Walayat Khan cold chain facility.
Road, Chaklala
Scheme 111,
Rawalpindi
90. M/s Platinum Shoukat -do- Yes Approved for storage of
Corporation, Rafique cold chain and room
F-10/7/6 Near temperature medical
Arfeen Masjid devices.
Barrage Colony,
Sukkur.

91. M/s Friends Traders, Asadullah Mr. No Approved for storage of

Head Office: Khan Lodhi. Muhammad room temperature
Ground Floor, Ayub Naveed, medical devices without
Peshawar Medical AD-II cold chain facility.
(MD&MC),
Centre, Hussain
DRAP,
Plaza, Shoba Chowk,
Islamabad.
Khyber Bazar,
Peshawar. Mrs. Unum
Godown Address: Zia Shamsi,
Lodhi Katrage, Old AD-IV
Bara Road, (MD&MC),
University Town, DRAP,
Peshawar. Islamabad.

92. M/s Haris Nasrullah. -do- Yes Approved for storage of

Enterprises, cold chain and room
Head Office: Sajjad Ullah. temperature medical
10A Karachi Market devices.
Khyber Bazar Shamsher Ali
Peshawar. Safi.
Godown Address:
35A Karachi Market
Khyber Bazar
Peshawar.

24
93. M/s Medilink Muhammad -do- No Approved for storage of
International, Islam room temperature
S-8 2nd Floor, Alfarid medical devices without
Center Eidgah Road, Abdullah cold chain facility.
Peshawar. Shah
Godown Address:
H.No.57, St. No. 2,
Zintara Town New
Ring Road, Near
Charsadda Road,
Peshawar.
94. Previous Address: Mr. Asim Approved.
M/s Asto Life Rauf,
Sciences (Pvt) Additional
Limited, 44/1 K- Director
Block, Model Town, (E&M)
Lahore. DRAP,
For Change of Lahore.
Establishment
Address (New
Address) as
mentioned below:
M/s Asto Life
Sciences (Pvt)
Limited, Plaza No.1,
Block Orchard 1,
Paragon City, Barki
Road, Lahore Cantt.

25
 Item No.III. APPLICATIONS FOR GRANT OF ENLISTMENT OF MEDICAL DEVICES FOR
IMPORT.

Secretary MDB informed the Board that the following applications for grant of
enlistment of medical devices for import on prescribed form 6-A under Medical Devices Rules,
2017 were received in the Division. The MDB discussed and decided as mentioned against earch:-

S. Name and Manufacture Name of Medical Brief Decisions

No Addresses of Details Device with Description
Establishment sizes/Class/Shelf Life

1. M/s Scilife Manufacturer: Sci Air Dry Powder Dry Powder Approved
Pharma (Pvt) Ltd., M/s Taian Dalu Inhaler Inhaler Device subject to
16, KOCHS Amir Medical Instrument registration of
Khusro Road, Co., Ltd., West Part Class A drug by the
Karachi of Yitianmen Street, Registration
Plot No. FD- Hi-tech Zone Taian, Shelf Life: 5 Years Board.
57/58-A2, Korangi Shandong
Creek Industrial DL-D01, DL-D02, DL-
Park (KCIP), (FSC China Valid D03,
Karachi Till DL-D04, DL-D05, DL-
12-03-2020) D06,
(ELI-00187) DL-D07, DL-D08

Evaluator: Fee submitted: Rs,

Hafiz Muhammad 5000/-
Asif Iqbal
2. M/s Hashir Legal Manufacturer: Bio Bag The Products Approved.
Surgicals Jiangsu Kangjin (Urine Bag) are clinically
Medical Instruments used for
1. Office No.16, Co., Ltd., 750ml, 2000ml educing and
Street 1, F-2, Address: Zhenglu storing the
Phase 6, Town, Changzhou Class A body fluid or
Hayatabad, City, China 213111 Shelf Life: 05 years urine with the
Peshawar. emiction tube
FSC China Fee submitted: Rs, and preventing
2. Office No.05, Valid till 14.12.2019 5000/- the cross
2nd Floor, infection of an
Syed’s Tower, infection or
University other
Road, complication of
Peshawar. treatment
effectively.
3. House No.2,
Street No.1,
Gulshan
Colony, GT

26
 Road,
Peshawar

Evaluator:
Muhammad Ayub
Naveed
3. M/s Sultansons, Manufacturer: Biotape Disposable Approved.
133 Kutchi Gali M/s Jiaxing Meson (Microporous surgical Surgical Tape,
#1, Marriott Road, Medical Material tape) Non-sterile
Karachi Co., Ltd.,
1F, Building 5, 1880 Class A
(ELI-00051) Renmin Road,
Wutong Street, Shelf Life: 2 Years
Evaluator: Tongxiang, Jiaxing,
Unum Zia Shamsi ZheJiang Province, 1.25cm x 450cm,
China 2.5cm x 450cm
5cm x 450cm, 7.5cm x
450cm,
(FSC China Valid 10cm x 450cm,
Till 10-05-2020) 1.25 cm x 274.32 cm
2.5 cm x 274.32 cm
5 cm x 274.32 cm
7.5 cm x 274.32 cm
10 cm x 274.32 cm

Fee submitted: Rs,

5000/-

4. -do- Manufacturer: Meson Disposable Approved.

M/s Jiaxing Meson (Adhesive wound Surgical Tape
Evaluator: Medical Material dressing tape) Roll, Non-
Unum Zia Shamsi Co., Ltd., 1F, sterile.
Building 5, 1880 Class A
Renmin Road,
Wutong Street,
Tongxiang, Jiaxing, Shelf Life: 2 Years
ZheJiang Provice,
China 10cm x 10m

(FSC China Valid Ref: MS6506

Till 10-05-2020)
Fee submitted: Rs,
5000/-

Item No.IV. APPLICATIONS FOR RENEWAL OF REGISTRATION OF MEDICAL DEVICES FOR

IMPORT.

27
 Secretary MDB informed the Board that the following applications for grant of renewal of
registration of medical devices for import on prescribed form 7-A under Medical Devices Rules,
2017 were received in the Division. The MDB discussed and decided as mentioned against earch:-

S. Name and Manufacture Name of Medical Device Brief Decisions

No Addresses of Details with sizes/Class/Shelf Description
Establishment Life

1. M/s Anthro Manufacture By: AB Disposable Infusion AB Disposable The Board

Pharmaceuticals M/s Shengguang Set (IV Set) Infusion Set approved the
(Pvt) Ltd., C19D, Medical Instrument renewal of
Badar Co., Ltd., Weiwu (Reg No. 074654) product subject
Commercial Road, Xincheng to foreign
Lane 5, Phase 5 District, Class B inspection
Ext, DHA, Pingdingshan City, under Rule 71
Shelf Life: 3Years
Karachi Henan Province. of Medical
A1, A3, A5, A6, A7, A8, Device Rules,
(ELI-00127) (FSC China Valid A9 2017.
Till 30-11-2023)

Fee submitted
Rs.100,000/-

2. M/s Anthro Manufacture By: AB Disposable Cannula AB Disposable The Board

Pharmaceuticals M/s Shengguang (Pen Type) Cannula (Pen approved the
(Pvt) Ltd., C19D, Medical Instrument Type) renewal of
Badar Co., Ltd., Weiwu (Reg No. 074653) product subject
Commercial Road, Xincheng to foreign
Lane 5, Phase 5 District, Class B inspection
Ext, DHA, Pingdingshan City, under Rule 71
Shelf Life: 3Years
Karachi Henan Province. of Medical
18G, 20G, 22G, 24G Device Rules,
(ELI-00127) (FSC China Valid 2017.
Till 30-11-2023)

Fee submitted
Rs.100,000/-

3. M/s Anthro Manufacture By: AB Disposable Syringe Disposable The Board

Pharmaceuticals M/s Shengguang (Luer Lock and Luer Slip): Syringe approved the
(Pvt) Ltd., C19D, Medical Instrument Conventional Syringe. renewal of
Badar Co., Ltd., Weiwu Safety-Syringe, AD product subject
Commercial Road, Xincheng Syringe, Insulin Syringe to foreign
Lane 5, Phase 5 District, inspection
Ext, DHA, Pingdingshan City, (Reg No. 074655) under Rule 71
Karachi Henan Province. of Medical
Class B Device Rules,
(ELI-00127) (FSC China Valid 2017.
Shelf Life: 5Years
Till 30-11-2023)
0.5ml, 1ml, 2ml, 3ml, 5ml,
28
 10ml, 20ml
Fee submitted
Rs.100,000/-

4. M/s B.Braun Manufacturer: Omnican® 100 (Insulin Sterile, Single Approved.

Pakistan (Pvt) M/s B. Braun Syringe) use Insulin
Ltd., Melsungen AG Carl- syringe for
The Forum, Braun-Strabe 1 34212 Class B subcutaneous
Suite 216, Melsungen, injection of
Shelf Life: 5 Years
Khayaban-e- Germany insulin.
Jami, Block 9,
Code:- 9151133S
Clifton, Karachi Manufacturing Site:
M/s Almo
Fee submitted:
(ELI-00006) Erzeugnisse Erwin
Rs.12,500/-
Busch GmbH Grobe
Allee 84 34454 Bad
Arolsen, Germany

(FSC Germany Issue

Date 05-05-2017)

Item No.V. CHANGE OF HEAD OFFICE ADDRESS

M/s Roche Pakistan Limited, Karachi have requested for change of their Head Office address on
their Establishment License as per details given below:-

Existing Address as per Establishment Proposed / New Address

License.
37-C, Block-6, P.E.C.H.S, Karachi 75400. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi
East 75400.

They have informed that the address of Warehouse will remain the same and the said change does
not have any impact on their Warehouse. The firm has submitted following documents:-

(i) Application on Form-2.

(ii) SECP Form-21 having new office address.
(iii) Copy of Certificate of Incorporation.
(iv) Declaration and Undertaking on stamp paper.
(v) Copy of Establishment License (ELI-00009) dated 03-08-2018.
(vi) Copy of DSL having new address.
(vii) Fee of Rs.10,000/-

Submitted for consideration of MDB please.

29
Decision: The Board acceeded to the request of the firm /company and approved their new Head
Office address.

Item No.VI. EXTENSION IN SHELF LIFE.

M/s Otsuka Pakistan Limited, Karachi has requested for extension in shelf life from 12 months to 2
years of their already registered following imported medical device (registered as drug):-

S.No. Regn. Name of Medical Device Approved Shelf

No. Life
(i) 081738 Firehawk Rapamycin Target Eluting 12 months
Coronary Stent System

The firm has submitted following documents:-

(i) Fee of Rs.5000/-.
(ii) DEKRA report.
(iii) Long term stability study of 24 months at 30ºC + 2ºC / 65% RH + 5% along with the
relevant attachments of the said medical device.
(iv) Legalized copy of approval of shelf life of the subject medical device by SFDA China.
(v) Original, valid and legalized Free Sale Certificate of the Netherlands.
(vi) Legalized CE marking documents

The case was placed before the MDB in its 11th meeting held on 1st February, 2019 and the MDB
decided as follows:-

"The Board decided to refer the matter to two Interventional Cardiologist for their opinion before extension
of shelf life of product."

Accordingly the matter was referred to Prof. Dr. Saqib Shafi Sheikh, Interventional
Cardiologist/Cardiovascular Surgeon, Mayo Hospital, Lahore and Maj. (Gen) (R) Dr. Azhar Mahmood
Kayani, Executive Director, Rawalpindi Institute of Cardiology, Rawalpindi for their opinion / comments
in the matter within 15 days.

In response to our letter, Prof. Dr. Saqib Shafi Sheikh, Interventional Cardiologist/Cardiovascular
Surgeon, Mayo Hospital, Lahore has stated that the shelf life of next supply of the above stent can be
increased to two years. However this cannot be applied to already existing stock in Pakistan imported
and stamped as one year shelf life. The response from Maj. (Gen) (R) Dr. Azhar Mahmood Kayani,
Executive Director, Rawalpindi Institute of Cardiology, Rawalpindi has not yet been received.

Submitted for consideration of MDB please.

Decision: The Board decided to refer the matter to Prof. Dr. Ejaz Ahmed, Interventional
Cardiologist, Multan Institute of Cardiology, Multan for opinion on extension of shelf
30
 life of Firehawk Rapamycin Target Eluting Coronory Stent System. The Board also
asked the firm to deposit Rs. 20000-/ differential fee for change in particulars. If an
opinion is received in favour of extension in shelf life, the approval shall be accorded
accordingly.

Item No. VII. REGISTRATION OF MEDICAL DEVICES PREVIOUSLY REGISTERED AS

DRUG.

Case No.01.

M/s Searle Company Limited, Karachi has applied for registration of the following medical
devices, previously registered as drug in the name of M/s Vertex Enterprises, Lahore.

S.# Regn.No. Brand Name of Packing Shelf Name of Manufacturer

Medical Device Life
(i) 059232 Medeco I.V. Cannula 100 per 5 years M/s Abu Dhabi
box Medical Devices Co.,
14G, 16G, 18G, 20G, Limited, United Arab
22G &24G. Eminates.

The firm has submitted following documents:-

(i) Application dossier alongwith Form 7-A for each product.

(ii) Copy of NOC from M/s Verrtex Enterprises, Lahore regarding transfer of registration of
above products.
(iii) Fee of Rs.100, 000/- for each product.
(iv) Letters of Authorization regarding above products from the foreign manufacturer wherein
it has also been mentioned that M/s Serale Company Limited, Karachi is their Exclusive
Agent/Distributor in the territory of Pakistan.

Sr Name of Name of Name of Medical Brief Description Remarks Evaluated

No. Importer Manufacturer Device by
1. M/s Searle Manufacturer: Medeco I.V. For the Mr.M.Ayu
Company M/s Abu Dhabi Cannula intravenous b Naveed,
Limited,1st Medical Devices administration of AD-II
Floor, Co. L.L.C, Class B medication and
N.I.C.L Mussafah City fluids.
Building, M43-Block 124, Shelf Life: 5 years
Abbasi P.O.Box 30485,
Shaheed Abu Dhabi,
Road, U.A.E. Fee submitted: Rs
Karachi. 100,000/-
(FSC valid till
(ELI-00057) 27-12-2020)

31
 It is submitted that M/s Searle Company Limited, Karachi has been issued Establishment Licence
to import Medical Devices under MDR, 2017 vide Licence No. ELI-00057, dated 3rd August, 2018.

Decision: The Board approved the product subject to inspection of the manufacturer abroad under
Rule 71 of Medical Device Rules, 2017. The Board also authorized the Secretary, MDB to
issue registration of the product if the manufacturing plant is approved by the panel of
experts.

Item No. VIII. CORRECTION OF BRAND NAME.

M/S Royal Enterprises, Karachi have informed that their following medical device manufactured
by M/s Foshan Tpmghe Medical Technology Co., Ltd, China has been enlisted as per detailed below:-

S.No. Reg.No. Medical Device Name

1 MDIE-0000023 Wheel Chair (All Sizes)

Class-A

The firm has submitted that brand name of medical device is UNIKA Wheel Chair while in the
enlistment letter the word "UNIKA" has not been mentioned. The firm has requested for issuance of
Corrigendum with complete brand name i.e. UNIKA Wheel Chair.
It is subitted that the brand name "UNIKA" was inadvertantly missed in agenda as well as in the
minutes of the 11th meeting of MDB.

Decision: The Board acceeded to the request of the firm /company and approved the brand name
"UNIKA Wheel Chair".

Item No. IX. CHANGE OF MANUFACTURER NAME

M/s Zenith International, Karachi have requested to approve the change of manufacturer name of
their following registered imported medical devices from M/s Sutures India Pvt Ltd, Plot No.13-16
KIADB Industrial Area, Kalanayakkanahalli, Kunigal Taluk, Tumkar District, Karnataka, India to M/s
Healthium Medtech Private Limited, Plot No.13-16 KIADB Industrial Area, Kalanayakkanahalli,
Kunigal Taluk, Tumkar District, Karnataka, India. The address of the manufacturer will remain same:-

32
 S.No. Reg. No. Name of Medical Device (s)
1. 081439 Trucath Foley Balloon Catheter

The firm has deposited the fee of Rs.25, 000/- for that purpose (pages 50 & 55/Corr) and
submitted following documents:-

(i) Copy of registration letter (pages 59-61/Corr)

(ii) Copy of Establishment Licence to import medical devices (page 62/corr).
(iii) Approval letter for change of company name isued by Drug Control Department,
Government of Karnataka (pages 63-89/Corr) attested by Embassy.
(iv) Free Sale Certificate of the product issued by Drug Control Department, Government of
Karnataka with the new company name i.e. M/s Healthium Medtech Private Limited, Plot
No.13-16 KIADB Industiral Area, Kalanayakkanahalli, Kunigal Taluk, Tumkar District,
Karnataka, India (Embassy attested) (pages 64-65/Corr).

(v) Certificate of Incorporation pursuant to change of name issued by Ministry of Corporate

Affairs, Government of India (page 66 /Corr).
(vi) EC Certificate (Production Quality Assurance) with the new company name (pages 67-
70/Corr).
(vii) ISO 13485 certificates with the new company name (page 71/Corr).
(viii) Authorization letter (page 72/Corr).
(ix) Copy of G.M.P Certificate with the new company name (page 73/Corr).

Decision: The Board acceeded to the request of the firm /company and approved change in name
of the firm to M/s Healthium Medtech Private Limited, Plot No.13-16 KIADB Industrial
Area, Kalanayakkanahalli, Kunigal Taluk, Tumkar District, Karnataka, India.

Item No. X. REDUCTION OF SHELF LIFE OF COROFLEX ISAR NEO SIROLIMUS-ELUTING

CORONARY STENT SYSTEM" REGISTRATION NO.083394

M/s B.Braun Pakistan (Pvt) Limited, Karachi has requested for reduction of shelf life of already
registered medical device (registered as drug) namely "Coroflex ISAR NeoSirolimus-eluting Coronary
Stent System" Registration No.083394 dated 10-03-2017 from 03 years to 02 years. The firm has submitted
following documents for perusal:-

(i) Form 7-A on the prescribed format dully filled and signed.
(ii) Copy of Establishment License.
(iii) Stability studies supporting shelf life claim of 24 months (2 years).
(iv) Fee of Rs.25000/-.
(v) Undetaking on stamp paper.

The case is being placed before the MDB with following details for its consideration please:-

Sr Name of Name of Name of Medical Brief Remarks

No Importer Manufacturer Device Description
.
33
 1. M/s Manufacturer: Coroflex ISAR NEO Drug
B.Braun B.Braun Sirolimus-eluting Eluting
Pakistan Melsungen AG Coronary Stent System Stent
(Pvt) Carl-Braun – Delivery
Limited, Stabe 1 34212 Dia Length (mm) System
The Melsungen, (m
Forum Germany. m)
Suite # Manufacturin 2.0 9,12,16,19,24,28,32,38.
216, g Site: B.Braun
Khayaban Melsungen AG 2.25 9,12,16,19,24,28,32,38.
-e-Jami, Vascular
Clifton Systems 2.5 9,12,16,19,24,28,32,38.
Block-9, Sieversufer 8,
Karachi 12359 Berlin, 2.75 9,12,16,19,24,28,32,38.
Germany.
(ELI- 3.0 9,12,16,19,24,28,32,38.
00006) FSC Germany.
Date of issue 3.5 9,12,16,19,24,28,32,38.
18-10-2016.
4.0 9,12,16,19,24,28,32,38.

Class-D
Shelf Life: 2 years

Decision: The Board acceeded to the request of the firm /company and approved the reduction in
shelf-life of their product Coroflex Isar Neo Sirolimus- Eluting Coronory Stent System
from three to two years.

Agenda Item XI : CERTIFICATE OF ENLISTMENT OR REGISTRATION OF A MEDICAL

DEVICE OR ACCESSORY OR COMPONENT FOR CONTRACT
MANUFACTURING.

Under rule 67 of Medical Devices Rules, 2017, manufacturing of medical devices may be
outsourced to contract acceptor having valid establishment licence issued by MDB under these rules.
For this purpose, MDB may determine conditions for such contract manufacturing. Furthermore, the
contract acceptor shall also possess establishment licence issued by the MDB. Under Rule 63(3) of
MDR, 2017, The Authority may, on the recommendation of MDB, amend Schedules A,B and D and
the Forms so as to omit any entry therefrom, add any entry thereto or amend any entry therein.

34
 Therefore, a Form namely, “Form-8B” Certificate of Enlistment or Registration of a medical
device or accessory or component for contract manufacturing as mentioned below is placed before
the MDB for consideration:-

DRUG REGULATORY AUTHORITY OF PAKISTAN

FORM-8B
[See rule 15(5), 67(1)]
CERTIFICATE OF ENLISTMENT OR REGISTRATION OF A MEDICAL DEVICE OR ACCESSORY
OR COMPONENT FOR CONTRACT MANUFACTURING

Licence No. ________________

Islamabad, Date of issue: ______________
F.No : _______________

M/s ………………..

The medical device as per details given below has been registered/enlisted on contract
manufacturing basis under the DRAP Act and the rules made there-under subject to the conditions
appearing hereinafter:

Enlistment or Name of medical device Brief description Class Shelf life

Registration or accessory or
No. component

(1) (2) (3) (4) (5)

Name of Contract Giver

Address of Contract Giver
Name of Contract Acceptor
Address of Contract Acceptor
Licence No. Contract Acceptor

2. This enlistment/registration shall be valid for a period of five years from the date mentioned
above unless earlier suspended or cancelled.
3. The name shall be changed in case it has resemblance with already enlisted/registered medical
device.
4. This enlistment/registration is subject to the conditions specified in the DRAP Act, 2012 and the
rules made there-under.

Secretary
Medical Device Board
Seal:

Decision: The Board recommended the FORM-8B, namely, Certificte of Enlistment or Registration
of a Medical Device or Accessory or Component for Contract Manufacturing for the

35
 approval of the Authority.

Item No.XII. PENDING CASES OF M/S UDL DISTRIBUTION (PVT) LIMITED, KARACHI.

In the last meeting i.e., 11 th MDB the following agenda was discussed and resultantly
decision was made by the MDB:
“M/s UDL Distribution (Pvt) Limited, Karachi has applied on Form-7A for registration of the following medical
devices manufactured by M/s Arrow International, Inc (Subsidiary of Teleflex, Incorporated) 2400 Bernville Road,
Reading PA 19605, USA under Medical Devices Rules, 2017:-

(i) Ultra-8 Intra Aortic Balloon Catheters.

(ii) Rediguard Intra Aortic Balloon Catheters.

(iii) Arrow Two-Lumen Hemodialysis Catheterization Set

(iv) Arrow Multi-Lumen Central Venous Catheterization Set
(v) Arrow Central Venous Catheterization Set
(vi) Ultra Intra Aortic Balloon Catheters.

(vii) Arrow Balloon Wedge Pressure Catheter.

(viii) Arrow Berman Angiographic Balloon Catheter.

It is submitted that the following medical devices including the above mentioned medical devices of the
same manufacturer have already been registered as drug with M/s Iqbal & Company, Islamabad on 21-02-2013.

S.No Reg.No. Name of drug (s) & Composition Packing MRP Approved
Shelf Life
1 074635 Arrow Central Venous 1’s Decontrolled till 05 Years
Catheterization Set policy decision by
the Federal
Government.

2. 074636 Arrow Intra Aortic Balloon 1’s -do- 2 years

Catheters.
3. 074637 Arrow Two Lumen Haemodialysis 1’s -do- 5 years
Catheterization Set.
4. 074638 Arrow Balloon Wedge Pressure 1’s -do- 2 years
Catheters.
5. 074639 Arrow Arterial Catheterization Set. 1’s -do- 5 years
6. 074640 Arrow Berman Angiographic 1’s -do- 18 months
Balloon Catheters

36
 7. 074641 Arrow Multi Lumen Access 1’s -do- 5 years
Catheters.

Letter of Authorization issued to M/s Iqbal & Company, Islamabad has expired on 31-12-2017 and the
manufacturer has not renewed the agreement. The manufacturer has appointed M/s UDL Distribution (Pvt)
Limited, Karachi as their distributor in Pakistan for their above products:-
Letters for personal hearing to M/s Iqbal & Company, Islamabad and M/s UDL Distribution (Pvt)
Limited, Karachi has been issued to clarify their status of Letter of Authorization.
Submitted for consideration of MDB please.

Decision: The Board heard both the importers, namely, M/s UDL (Pvt) Limited, Karachi and M/s Iqbal &
Company, Islamabad at length. Mr. Arshad Abdullah, Director Sales and Mr. Arshad Malik, CEO
made their appearance on behalf of M/s UDL (Pvt) Limited, Karachi and M/s Iqbal & Company,
Islamabad respectively.
It was noticed by the Board that the same principal, namely, M/s Arrow International, Inc
(Subsidiary of Teleflex, Incorporated) 2400 Bernville Road, Reading PA 19605, USA has given their
same products to both the importers. M/s Iqbal & Company was of the opinion that they have a stock of
products under consideration for cancellation and has to fulfill tender supply commitments at various
institutions / hospitals, and requested M/s UDL (Pvt) Limited, Karachi to take their stock in order to
settle the matter. The representative from M/s UDL (Pvt) Limited, Karachi has agreed in front of the
Board to take the stock of M/s Iqbal & Company, Islamabad.
The Agency Agreement in the name of M/s Iqbal & Company, Islamabad has not been
renewed by the principal, while M/s UDL (Pvt) Limited, Karachi has the Agency Agreement therefore
the above mentioned products were cancelled in the name of M/s Iqbal & Company, Islamabad and were
registered in the name of M/s UDL (Pvt) Limited, Karachi for which application on Form 7A are
submitted.”

Mr Arshad Abdullah, Director M/S UDL Distribution (Pvt) Limited has written a letter
to Chairman, MDB on 18-04-2018. The contents of the letter are reproduced below:

“ We would like to refer to our cases of product registration pending with Medical Devices Board
since October, 2018. In this respect the board meeting was held on 01 st Feb, 2019 in Islamabad.
The previous distributor M/S Iqbal & Company & UDL were represented in the meeting by Mr.
Arshad Malik (owner) and myself respectively. After hearing from both side, the board decided as
follows;
 The product registration previously held by Iqbal &co. would be cancelled as their
distribution agreement with Teleflex was terminated in Feb.2018.
 Products registration would be transferred to M\S UDL Distribution (Pvt) Ltd. being
the authorized distributer for M\S Teleflex in Pakistan.

37
  In order to facilitate M\S Iqbal &Co., the board gave directives to UDL to support in
terms of purchasing unsold stock lying with M\S Iqbal & and Co. & provide stocks to
M\S Ibal & Co. in order for Iqbal & Co. to fulfill contractual obligations pertaining to
year 2018.

The board meeting was headed by Mr. Dr. Abdul Aleem Khan. The board instructed UDL to
confirm the same in writing to Iqbal & Co. with copy to board and UDL’s case products
registration would be processed accordingly. UDL acted upon the directives of board in good
gesture and confirmed the same twice in writing to Iqbal & Co. on dated 13 th Feb, 2019 and 27th
Mar, 2019 with copy to board (copies enclosed).

However, during the period of Seventy two days, M\S Iqbal & Co. responded four times (copies
enclosed) and each time with different stance and unreasonable claims and very through their
correspondence, you would endorse our view point.

Based on the developments so far, we are of the opinion;

 The M/S Iqbal & Co is using unlawful tactics and their sole intension is to delay
UDL’s product registration to their own benefits. We understand that their other
brand in direct competition with UDL’s is in registration process and they intend
to take advantage by complicating the matters.
 They are trying to indulge UDL in matters that are solely associated with M/S
Iqbal & Co and M/S Teleflex. They are also involving MDB in matters which are
beyond the domain of MDB.
 UDL has already suffered heavy losses due to delay in issuance of product
registration and several government and private institutions are in dire need of the
products. MDB has also been approached by several institutions in this regards.
 Last but not the least, the goodwill gesture by MDB and UDL to support Iqbal &
Co had been misunderstood as our weakness without realizing the spirit behind our
gesture.
We very strongly request you to kindly issue directivesfor issuance of product registration to UDL
and oblige.

Decision: The Board deliberated the matter at length and decided that M/S UDL Distribution (Pvt)
Limited shall fulfill the liabilities at the consumer end in terms of warranty/services or
replacement of defective or short expiry medical devices. The Board observed that any
replacement of expired stock lying with the M/s Iqbal & Co. or any financial liability is a
matter related to the importer and its principal abroad. The Board permitted to issue the
registration certificates of products of M/s UDL Distribution (Pvt) Limited.

Item No.XIII. APPLICATIONS FOR GRANT OF REGISTRATION OF MEDICAL DEVICES FOR

IMPORT.

38
 Secretary MDB informed the Board that the following applications for grant of registration
of medical devices for import on prescribed form 7-A under Medical Devices Rules, 2017 were
received in the Division. The MDB discussed and decided as mentioned against earch:-

S. Name and Manufacture Details Name of Medical Brief Decisions

No Addresses of Device with Description
Establishment sizes/Class/Shelf Life

1. M/s Apsta Manufacturer: Endomat Plus For Approved.

International, M/s Laboratorium Dr. Viruguard Disinfection
38-A Johar Deppe GmbH Hooghe Composition: and Cold
Town, Lahore Weg 35, 47906 Kempen, Sterilization of
Germany 100 gm contains: Medical
(ELI-00042) Glutaraldehyde 20 gm Devices
(FSC Germany Issuance
Evaluator: Date 31-10-2016) Pack Size:
Muhammad 50ml,500ml, 1000ml,
Ayub Naveed 5000ml
Fee submitted
Rs.50,000/- Class C
Shelf Life: 3 Years

2. -do- Manufacturer: Endo Star NEU Instrument Approved.

M/s Laboratorium Dr. Disinfectant
Evaluator: Deppe GmbH Hooghe Composition:
Muhammad Weg 35, 47906 Kempen, Alkyldimethylethyl
Ayub Naveed Germany ammonium methyl
sulfate……. 5 % (w/w)
(FSC Germany Issuance Polyhexamethyl
Date 31-10-2016) enbiguanid
hydrochloride…… 1 %
Fee submitted (w/w)
Rs.50,000/- Cocospropylenguanidi
um diacetate
………..1.8 % (w/w)

Pack Size:
50ml,500ml, 1000ml,
5000ml
Class C
Shelf Life: 3 Years

3. M/s PharmEvo Manufacturer: EvoCheck Blood Blood Glucose Deferred.

(Pvt) Ltd., A-29, M/s Bionime Glucose Monitoring Meter The Board
North Western Corporation Daoing System referred the
Industrial Zone, Factory, No. 100, Sec 2, matter to
Port Qasim, Daqing St. Taichung City Class C Foreign
Karachi 40242, Taiwan Office for
39
 Shelf Life: 2 Years seeking
(ELI-00055) (FSC China Issuance clarification
Date 02-11-2021) of foreign
Evaluator: inspection in
Muhammad Fee submitted Taiwan.
Ayub Naveed Rs.50,000/-

4. -do- Manufacturer: EvoCheck Blood Blood Glucose Deferred.

M/s Bionime Glucose Test Strips Test Strip The Board
Evaluator: Corporation Daoing referred the
Muhammad Factory, No. 100, Sec 2, Class C matter to
Ayub Naveed Daqing St. Taichung City Foreign
40242, Taiwan Shelf Life: 24 Months Office for
seeking
(FSC China Issuance clarification
Date 02-11-2021) of foreign
inspection in
Taiwan.
Fee submitted
Rs.50,000/-

5. M/s Muller & Manufacturer: Contour Plus Blood Blood Glucose Approved.
Phipps Pakistan M/s Ascensia Diabetes Monitoring System Monitoring
(Pvt) Ltd., Uzma Care Holdings AG, Peter system
Court, Main Merian-Strasse 90, 4052 Class C
Clifton Road, Basel, Switzerland
Karachi Shelf Life: 24 Months
(FSC SwitzerlandValid
(ELI-00030) Till 19-03-2020)

Evaluator: Fee submitted

Muhammad Rs.50,000/-
Ayub Naveed
6. -do- Manufacturer: ContourTM TS Blood Blood Glucose Approved.
M/s Ascensia Diabetes Glucose Monitoring Monitoring
Evaluator: Care Holdings AG, Peter System system
Muhammad Merian-Strasse 90, 4052
Ayub Naveed Basel, Switzerland Class C

(FSC SwitzerlandValid Shelf Life: 5 Years

Till 19-03-2020)

Fee submitted
Rs.50,000/-

7. -do- Manufacturer: ContourTM Plus Blood Blood Glucose Approved.

M/s Ascensia Diabetes Glucose Test Strips Test Strips
Evaluator: Care Holdings AG, Peter
Muhammad Merian-Strasse 90, 4052 Class C
Ayub Naveed Basel, Switzerland
Shelf Life: 24 Months
(FSC SwitzerlandValid
40
 Till 19-03-2020) Pack size:
10 Counts Test Strips
Fee submitted 25 Counts Test Strips
Rs.50,000/- 2x25 CountsTest Strips
50 Counts Test Strips
2x50 Counts Test Strips

8. -do- Manufacturer: Contour TS Test Strips Contour TS Approved

M/s Ascensia Diabetes Blood Glucose subject to
Evaluator: Care Holdings AG, Peter Pack size: Test Strips audit report.
Muhammad Merian-Strasse 90, 4052 10 Counts Test Strips
Ayub Naveed Basel, Switzerland 25 Counts Test Strips
2x25 CountsTest Strips
(FSC SwitzerlandValid 50 Counts Test Strips
Till 19-03-2020) 2x50 Counts Test Strips

Fee submitted Class C

Rs.50,000/-
Shelf Life: 24 Months
9. -do- Manufacturer: ContourTM TS Blood The ContourTM Approved.
M/s Ascensia Diabetes Glucose Monitoring TS Blood
Evaluator: Care Holdings AG, Peter System Glucose
Muhammad Merian-Strasse 90, 4052 Monitoring
Ayub Naveed Basel, Switzerland Class C System utilizes
amperometic
(FSC SwitzerlandValid Shelf Life: 5 Years biosensor
Till 19-03-2020) technology to
quantitatively
Fee submitted measure the
Rs.50,000/- glucose
concentration
in whole blood
or in Contour
TS Control
Solutions.
10. -do- Manufacturer: ContourTM Plus Blood The ContourTM Approved.
M/s Ascensia Diabetes Glucose Test Strips Plus Blood
Evaluator: Care Holdings AG, Peter Glucose Test
Muhammad Merian-Strasse 90, 4052 Class C Strips is
Ayub Naveed Basel, Switzerland designed for
Shelf Life: 24 Months use with the
(FSC Switzerland Valid Contour Plus
Till 19-03-2020) Blood Glucose
Meter. The test
Fee submitted provides a
Rs.50,000/- quantitative
measurement
of glucose in
blood from 10
to 600mg/ dL
(0.6 to
33.3mmol/L)
41
11. M/s 4S Manufacturer: Sterile Hemostasis Sterile Approved.
International, M/s APT Medical Inc., Introducer Hemostasis
Suite No. 205, 2nd No. 009, Xiangxiang Introducer
Floor Al-Fiza Road, Xiangxiang Class D
Glass Tower Economic Development
Shelf Life: 3 years
Rashid Minhas Zone, Xiangxiang City
Road, Block 10-A Hunan, 411400, PR
Codes & Sizes as per
Gulshan e Iqbal China
German FSC No.
Road, Karachi
0362/2018 dated 21st
(FSC Germany Issuance
August, 2018
(ELI-00290) Date 14-08-2018)

Evaluator: Fee submitted

Muhammad Rs.50,000/-
Ayub Naveed
12. -do- Manufacturer: ConquerorTM PTCA ConquerorTM Approved.
M/s APT Medical Inc., Balloon Catheter PTCA Balloon
Evaluator: No. 009, Xiangxiang Catheter
Muhammad Road, Xiangxiang Class D
Ayub Naveed Economic Development
Shelf Life: 3 years
Zone, Xiangxiang City
Hunan, 411400, PR
Codes & Sizes as per
China
German FSC No.
0362/2018 dated 21st
(FSC Germany Issuance
August, 2018
Date 14-08-2018)
Fee submitted
Rs.50,000/-

13. -do- Legal Manufacturer: Infusion Pump, General Vloumetric Approved.

M/s Mediquip Pty Ltd 3 Purpose (Volumetric) Infusion Pump
Evaluator: Henry Street
Muhammad Loganholme QLD 4129, Class C
Ayub Naveed Australia
Shelf Life: 3 Years
Manufacturer:
ARTG:287600
M/s Medima Ltd., 200
Al Jerozolimskie Warsaw
Fee submitted
02-486, Poland
Rs.50,000/-
(FSC Australia Issuance
Date18-04-2018)

14. -do- Legal Manufacturer: Syringe Infusion Pump Syringe Approved.

M/s Mediquip Pty Ltd 3 Infusion Pump
Evaluator: Henry Street Class C
Muhammad Loganholme QLD 4129,
Shelf Life: 3 Years
Ayub Naveed Australia
ARTG:287596
Manufacturer:
M/s Medima Ltd., 200
Fee submitted
Al Jerozolimskie Warsaw
42
 02-486, Poland Rs.50,000/-

(FSC Australia Issuance

Date 18-04-2018)
15. -do- Manufacturer: APT Medical Guidewire Approved.
M/s APT Medical Inc., Hydrophilic Guidewire
Evaluator: No. 009, Xiangxiang
Hafiz Road, Xiangxiang Class D
Muhammad Asif Economic Development
Shelf Life: 3 years
Iqbal Zone, Xiangxiang City
Codes and sizes as per
Hunan, 411400, PR
FSC.
China

Authorized
Representative:
M/s Shanghai
International Holding
Corp. GmbH (Europe)
Eiffestrabe 80 20357
Hamburg, Germany
(FSC Germany Issuance
Date 14-08-2018)
Fee submitted
Rs.50,000/-

16. -do- Manufacturer: ExpressmanTM Guiding Catheter Approved.

M/s APT Medical Inc., Extension Catheter
Evaluator: No. 009, Xiangxiang
Hafiz Road, Xiangxiang Class D
Muhammad Asif Economic Development
Shelf Life: 3 years
Iqbal Zone, Xiangxiang City
Hunan, 411400, PR
Codes and sizes as per
China
FSC
Authorized
Representative:
M/s Shanghai
International Holding
Corp. GmbH (Europe)
Eiffestrabe 80 20357
Hamburg, Germany

(FSC Germany Issuance

Date 14-08-2018)
Fee submitted
Rs.50,000/-

17. -do- Manufacturer: APT Medical Microcatheter Approved.

M/s APT Medical Inc., Microcatheter
Evaluator: No. 009, Xiangxiang
Hafiz Road, Xiangxiang Class D
43
 Muhammad Asif Economic Development Shelf Life: 3 years
Iqbal Zone, Xiangxiang City
Hunan, 411400, PR Codes and sizes as per
China FSC

Authorized
Representative:
M/s Shanghai
International Holding
Corp. GmbH (Europe)
Eiffestrabe 80 20357
Hamburg, Germany

(FSC Germany Issuance

Date 14-08-2018)
Fee submitted
Rs.50,000/-

18. -do- Manufacturer: MarchTM Guiding Guiding Approved.

M/s APT Medical Inc., Catheter Catheter
Evaluator: No. 009, Xiangxiang
Hafiz Road, Xiangxiang Class D
Muhammad Asif Economic Development
Shelf Life: 3 years
Iqbal Zone, Xiangxiang City
Hunan, 411400, PR
Codes and sizes as per
China
FSC
Authorized
Fee submitted
Representative:
Rs.50,000/-
M/s Shanghai
International Holding
Corp. GmbH (Europe)
Eiffestrabe 80 20357
Hamburg, Germany

(FSC Germany Issuance

Date 14-08-2018)

19. -do- Manufacturer: APT Medical Hydrophilic Approved.

M/s APT Medical Inc., Hydrophilic Angiographic
Evaluator: No. 009, Xiangxiang Angiographic Catheter Catheter
Hafiz Road, Xiangxiang
Muhammad Asif Economic Development Class D
Iqbal Zone, Xiangxiang City
Shelf Life: 3 years
Hunan, 411400, PR
China.
Codes and sizes as per
FSC
Authorized
Representative:
Fee submitted
M/s Shanghai
Rs.50,000/-
International Holding
Corp. GmbH (Europe)
44
 Eiffestrabe 80 20357
Hamburg, Germany

(FSC Germany Issuance

Date 14-08-2018)

20. M/s Mana & Manufacturer: Medicare Sterile IV Sterile IV Approved

Co., Office No. M/s Jiangxi Huali Catheter Catheter for subject to
401, 4th Floor, Medical Instrument Co single use. provision of
Masood Ltd., Yudu Industrial Class B stability data.
Chamber, Zone, Jiangxi, China
Shahrah-e- Shelf Life: 3 Years
Liaquat, Karachi (FSC China Valid Till
03-11-2017)
(ELI-00098)

Evaluator:
Hafiz
Muhammad Asif
Iqbal
21. A.H Manufacturer: URSA Angiographic Angiographic Approved.
Distributors: M/s. Curatia Medical Catheter Coronary
House No. CB- Limited Address:198 Catheter
708, Lane No. 5, Xiangjiang Road, New Class D
Peshawar Road, District, Suzhou 215011,
Rawalpindi China. Shelf Life: Three years

(ELI-00225) FSC USFDA valid till 25- Codes and sizes as per
11-2020 USFDA FSC No. 2043-
Evaluator: 11-2018
Muhammad
Ayub Naveed Fee submitted
Rs.50,000/-

22. -do- Manufacturer: MSM DES Sirolimus Approved.

Micro Science Medical Eluting Stent System
Evaluator: AG
Muhammad Meisenweg 5, D-75443 Class D
Ayub Naveed Oetisheim, Germany
Shelf Life 36 months
FSC Germany issue date
16-10-2018 Codes and sizes:

Codes and sizes as per 2,25x8mm; 2,25x10mm;

USFDA FSC No. 2043-11- 2,25x13mm;
2018 2,25x16mm;
2,25x18mm;
Fee submitted 2,25x23mm;
Rs.50,000/- 2,25x28mm; 2,50x8mm;
2,50x10mm;
2,50x13mm;
2,50x16mm;
45
 2,50x18mm;
2,50x23mm;
2,50x28mm;
2,50x33mm;
2,50x38mm; 2,75x8mm;
2,75x10mm;
2,75x13mm;
2,75x16mm;
2,75x18mm;
2,75x23mm;
2,75x28mm;
2,75x33mm;
2,75x38mm; 3,00x8mm;
3,00x10mm;
3,00x13mm;
3,00x16mm;
3,00x18mm;
3,00x23mm;
3,00x28mm;
3,00x33mm;
3,00x38mm; 3,25x8mm;
3,25x10mm;
3,25x13mm;
3,25x16mm;
3,25x18mm;
3,25x23mm;
3,25x28mm;
3,25x33mm;
3,25x38mm; 3,50x8mm;
3,50x10mm;
3,50x13mm;
3,50x16mm;
3,50x18mm;
3,50x23mm;
3,50x28mm;
3,50x33mm;
3,50x38mm; 4,00x8mm;
4,00x10mm;
4,00x13mm;
4,00x16mm;
4,00x18mm;
4,00x23mm;
4,00x28mm;
4,00x33mm; 4,00x38mm
23. -do- Manufacturer: MSM PTCA SC Balloon Semi- Approved.
Micro Science Medical Catheter Compliant
Evaluator: AG Class D Coronary
Muhammad Meisenweg 5, D-75443, Shelf Life 36 Months Balloon
Ayub Naveed Oetisheim, Germany Catheter
1.5x10/15/20/25/30/3
FSC Germany issue date 5/40
16-10-2018 1.75x10/15/20/25/30/
46
 35/40
Codes and sizes as per 2.0x10/15/20/25/30/3
USFDA FSC No. 2043-11- 5/40
2018 2.25x10/15/20/25/30/
35/40
Fee submitted 2.5x10/15/20/25/30/3
Rs.50,000/- 5/40
2.75x10/15/20/25/30/
35/40
3.0x10/15/20/25/30/3
5/40
3.5x10/15/20/25/30/3
5/40
4.0x10/15/20/25/30/3
5/40
24. -do- Manufacturer: MSM CIS Cobalt Bare Metal Approved.
Micro Science Medical Chromium Bare Metal Cobalt The shelf life
Evaluator: AG Coronary Stent System Chromium of the
Muhammad Meisenweg 5, D-75443, Cardiac Stent product is 3
Ayub Naveed Oetisheim, Germany 2.25x8/13/18/23/28, years.
2.5x8/13/18/23/28/33
FSC Germany issue date /38,
16-10-2018 2.75x8/13/18/23/28/3
3/38,
Fee submitted 3.0x8/13/18/23/28/33
Rs.50,000/- /38,
3.5x8/13/8/23/28/33/
38,
4.0x8/13/18/23/28/33
/38

25. M/s Nasir Manufacturer: V. Cath I.V Cannula IV Cannula for Approved
Brothers, 22B, 2nd M/s Nanchang Biotek single use. subject to
Floor, Zeenat Medical Technology Class B foreign
Medicine Company Limited., No. inspection of
Market, North 738, Youkou Road, High- manufacturer
Napire Road, Tech Development Zone, Shelf Life: 3 Years abroad. The
Karachi Nanchang, Jiangxi, Board also
China authorized
Sizes: 26G, 24G, 20G,
(ELI-00036) the Secretary
18G, 16G, 14G
(FSC China Valid Till MDB to issue
Evaluator: 25-09-2019) registration
Muhammad of the
Ayub Naveed Fee Submitted product, if
Rs.25,000/- the panel of
experts
approve the
manufacturin
g plant.

26. -do- Manufacturer: Vcare Connecting Tube Connecting Approved

47
 M/s Ningbo MFLAB with Yankauer Handle Tube with subject to
Evaluator: Medical Instruments Co., Yankauer foreign
Muhammad Ltd., No.508, Yindong Class B Handle inspection of
Ayub Naveed Road(N) Yinzhou manufacturer
Shelf Life: Not
Economic Development abroad. The
Zone315145 Ningbo, Mentioned Board also
China authorized
the Secretary
X01-PY, X01-PW,
(FSC China Valid Till MDB to issue
…………..
22-05-2020) registration
Codes & sizes as per
Fee Submitted of the
FSC.
Rs.25,000/- product, if
the panel of
experts
approve the
manufacturin
g plant.

27. -do- Manufacturer: Vcare Nasal Oxygen Nasal Oxygen Approved

M/s Ningbo MFLAB Cannula Cannula subject to
Evaluator: Medical Instruments Co., foreign
Muhammad Ltd., No.508, Yindong Class B inspection of
Ayub Naveed Road(N) Yinzhou manufacturer
Shelf Life: Not
Economic Development abroad. The
Zone315145 Ningbo, Mentioned Board also
China authorized
the Secretary
B01-L, B01-S, B01-XS,
MDB to issue
B01-XXS, B02-L, B02-S,
(FSC China Valid Till registration
B02-XS, B02-XXS
22-05-2020) of the
product, if
the panel of
Fee Submitted experts
Rs.25,000/- approve the
manufacturin
g plant.

28. -do- Manufacturer: VCARE Nebulizer Nebulizer Approved

M/s Ningbo MFLAB Mask for Single Use Mask for subject to
Evaluator: Medical Instruments Co. Single Use foreign
Muhammad Ltd., No. 508, Yindong Class B inspection of
Ayub Naveed (N) Yinzhou Economic manufacturer
Shelf Life: 5 Years
Development Zone abroad. The
315145 Ningbo, China S04-XL, S04-L, S04-L2, Board also
S04-L3, S04-M, S04-M2, authorized
(FSC China Valid Till S04-S, S04-XS the Secretary
22-05-2020) MDB to issue
registration
Fee Submitted of the
Rs.25,000/- product, if
the panel of
experts
48
 approve the
manufacturin
g plant.

29. -do- Manufacturer: LONGFIANG Medical Medical Approved

M/s Longfian Scitech Oxygen Concentrator Oxygen subject to
Evaluator: Co. Ltd., 2F & 3F, East Concentrator foreign
Hafiz Section, Building 12, Class B inspection of
Muhammad Asif Power Valley manufacturer
Iqbal PioneerPark, No.369, abroad. The
Huiyang Street, 071051, Shelf Life: 5 Years or Board also
Baoding, Hebei Province, authorized
20000Hrs
China the Secretary
MDB to issue
(FSC China Valid Till Model: JAY-5 registration
02-09-2020) (20172540088) of the
product, if
Fee Submitted the panel of
Rs.25,000/- experts
approve the
manufacturin
g plant.

Also subject
to provision
of Stability
study.
30. -do- Manufacturer: VCARE Disposable Disposable Approved
M/s Shangai Yuechen ECG Electrodes ECG subject to
Evaluator: Medical Supply Co. Ltd., Electrodes foreign
Hafiz 8th Building No. 776 Class B inspection of
Muhammad Asif Huhang Road, Fengxian manufacturer
Shelf Life: 5 Years
Iqbal District, Shanghai City, abroad. The
China HS07, HS08, HS09, Board also
HS10, HS11, HS12, authorized
(FSC China Valid Till HS13; HW01, HW02, the Secretary
02-05-2020) HW03, HW04, HW05, MDB to issue
HW06, HW07, HW08, registration
Fee Submitted HW09, HW10, HW11, of the
Rs.25,000/- HW12, HW13, HW14; product, if
HA01, HA02, HA03, the panel of
HA04, HA05, HA06, experts
HA07, HA08, HA09, approve the
HA10, HA11, HA12, manufacturin
HA13 g plant.

Also subject
to provision
of Stability
study.

Also subject
49
 to provision
of Stability
study.
31. -do- Manufacturer: VCARE Sterile Syringes Sterile Approved
M/s Changzhou Jinlong for single use (with Syringes for subject to
Evaluator: Medical Plastic needle) single use provision of
Hafiz Appliance Co. Ltd., (with needle) Stability
Muhammad Asif Zhennan Road, Zhenglu Class B study and
Iqbal Town, Changzhou City, Embassy
Shelf Life: 5 Years
Diangsu Province, China Attested Free
1mL, 2mL, 3mL, 5mL, Sale
(FSC China Valid Till 10mL, 20mL Certificate
22-05-2020) from
Pakistan
Copy of FSC of UK is Embassy in
provided . UK.

Rs.100,000/-
Already submitted
against slip no. 0560700
dated 16-11-2016

32. -do- Manufacturer: VCARE Oxygen masks Oxygen masks Approved

M/s Ningbo MFLAB for single use for single use subject to
Evaluator: Medical Instruments Co. provision of
Hafiz Ltd., No. 508, Yindong Class B Stability
Muhammad Asif (N) Yinzhou Economic study and
Shelf Life: 5 Years
Iqbal Development Zone Embassy
315145 Ningbo, China S01-XL, S01-L, S01-L2, Attested Free
S01-L3, S01-M, S01-M2, Sale
Copy of FSC of UK is S01-S, S01-XS Certificate
provided . from
Pakistan
(FSC China Valid Till Embassy in
22-05-2020) UK.

Rs.25,000/-

33. -do- Manufacturer: VCARE Sterile Infusion Sterile Infusion Approved

M/s Changzhou Jinlong Sets for SingleUse (with Sets for subject to
Evaluator: Medical Plastic needle) SingleUse provision of
Hafiz Appliance Co. Ltd., (with needle) Stability
Muhammad Asif Zhennan Road, Zhenglu Class B study and
Iqbal Town, Changzhou City, Embassy
Shelf Life: 5 Years
Diangsu Province, China Attested Free
ISI-G-Z, IS2-G-Z, IS3-G- Sale
(FSC China Valid Till Z, IS4-G-Z, IS5-G-Z, Certificate
22-05-2020) IS6-G-Z, IS7-G-Z, IS8- from
G-Z, IS9-G-Z, IS10-G-Z Pakistan
Rs.100,000/- (0.45, 0.5, 0.55, 0.6, 0.7, Embassy in
50
 Already submitted 0.8, 0.9, 1.1, 1.2) UK.
against slip no. 0560700
dated 16-11-2016
34. M/s S. Manufactured By: JMS Transfer Pack Blood Transfer Approved
Ejazuddin & Co., M/s JMS Singapore PTE Pack intended subject to
PO Box 5629, Zia Ltd., 440 ANG MO Kio Class C for separating foreign
Plaza, Altaf Industrial Park 1, 569620 blood inspection of
Hussain Road, Singapore Shelf Life: 3Years components manufacturer
Karachi from whole abroad. The
(FSC Singapore Valid Till 300ml blood. Board also
(ELI-00078) 15-08-2019) authorized
the Secretary
Evaluator: Fee Submitted MDB to issue
Muhammad Rs.50,000/- registration
Ayub Naveed of the
product, if
the panel of
experts
approve the
manufacturin
g plant.

35. -do- Manufactured By: JMS Extension Tube Extension Approved

M/s JMS Singapore PTE Tube intended subject to
Evaluator: Ltd., 440 ANG MO Kio Class C for extending foreign
Muhammad Industrial Park 1, 569620 fluid pathway inspection of
Ayub Naveed Singapore Shelf Life: 3Years lines, manufacturer
connecting abroad. The
(FSC Singapore Valid Till ET 2 500MM CE, with infusion Board also
15-08-2019) ET 2 825MM CE, set, syringe or authorized
ET 2 1000MM CE, other infusion the Secretary
Fee Submitted ET 2 1500MM CE devices in a MDB to issue
Rs.50,000/- ET 2 2000MM W/LUER way that allow registration
SLIP CE IV tubing to be of the
M.V.E.T 500MM changed away product, if
W/LUER SLIP CE from insertion the panel of
site, thereby experts
reducing risk approve the
of manufacturin
contamination. g plant.

36. M/s Timax Life Manufacturer: Flaminal Hydro Wound Approved.

Sciences (Pvt) M/s Flen Pharma NV- (Enzyme Alginogel) healing
Ltd., M-1, FL-37, Blauwesteenstraat 87- hydrogel(with
Block B, 2550 Kontich, Belgium Class C less conc. of
Gulshan-e-Jamal, alginate
Shelf Life: 2 Years
Karachi (FSC Belgium Issuance Fluminal Fort)
Date keeps the
10g tube,15g tube, 25g
(ELI-00309) 08-05-2018) wound clean
tube, 30g tube, 40g
and moist and
tube,50g tube, 500g jar
Evaluator: Fee Submitted leads to
51
 Hafiz Rs.50,000/- continuous
Muhammad Asif debridement
Iqbal of the wound.
37. -do- Manufacturer: Flaminal Forte Wound Approved.
M/s Flen Pharma NV- healing
Evaluator: Blauwesteenstraat 87- Class C hydrogel.
Hafiz 2550 Kontich, Belgium Keeps the
Shelf Life: 2 Years
Muhammad Asif wound clean
Iqbal (FSC Belgium Issuance and moist and
10g tube,15g tube, 25g
Date leads to
tube, 30g tube, 40g
08-05-2018) continuous
tube,50g tube, 500g jar
debridement
Fee Submitted of the wound..
Rs.50,000/-

38. do- Manufacturer: Perifix® (Set for Set for Approved.

M/s B. Braun Melsungen Continuos epidural Continuos
Evaluator: AG Carl-Braun-Strabe 1 anaesthesia) Epidural
Hafiz 34212 Melsungen, Anaesthesia
Muhammad Asif Germany Class D
Iqbal
Shelf Life: 5 Years
Manufacturing Site:
M/s Braun Medical
4514017, 4514025
Industries Sdn. Bhd.,
Bayan Lepas Free
Fee Submitted
Industrial Zone 11900
Rs.50,000/-
Penang, Malaysia

(FSC Germany Issuance

Date
10-01-2019)

39. M/s Hoora Legal Manufacturer/ Immulite 1000 Rubella IgG Approved.
Pharma (Pvt) Manufacturing Site: IGM Assay Antibodies to
Ltd., WH-01-20- M/s Siemens Healthcare the Rubella
A7-A8, Korangi Diagnostics Products i) Immulite 1000 Virus Group
Creek Industrial Limited, Glyn Rhonwy, Rubella IGM Assay
Park, Karachi Llanberis, Caernarfon, SMN 10381282 REF
LL55 4EL, UK LKRM1
(ELI-00037)
(FSC UK Valid Till ii) Immulite 1000
Evaluator: 16-10-2020) IGG/IGM (ID1) Sample
Muhammad Diluent Module
Ayub Naveed Fee Submitted SMN 10387608 REF
Rs.50,000/- L1KIGW1

Class C
Shelf Life: 12 Months

40. -do- Legal Manufacturer/ Immulite 1000 CMV IgG Approved.

Manufacturing Site: IGG Assay Antibodies to
52
 Evaluator: M/s Siemens Healthcare Cytomegalovir
Muhammad Diagnostics Products i) Immulite 1000 CMV us Assay
Ayub Naveed Limited, Glyn Rhonwy, IGG Assay
Llanberis, Caernarfon, SMN 10381289 REF
LL55 4EL, UK LKCV1

(FSC UK Valid Till ii) Immulite 1000

16-10-2020) IGG/IGM (ID1) Sample
Diluent Module
Fee Submitted SMN 10387608 REF
Rs.50,000/- L1KIGW1

Class C
Shelf Life: 12 Months

41. -do- Legal Manufacturer/ Immulite 2000 PSA Prostate- Approved.

Manufacturing Site: Assay Specific
Evaluator: M/s Siemens Healthcare Antigen Assay
Muhammad Diagnostics Products i) Immulite 2000 PSA
Ayub Naveed Limited, Glyn Rhonwy, Assay
Llanberis, Caernarfon, SMN 10380986 REF
LL55 4EL, UK L2KPS2 (200 Tests)
(FSC UK Valid Till SMN 10380996 REF
16-10-2020) L2KPS6 (600 Tests)

Fee Submitted ii) Immulite PSA

Rs.50,000/- Sample Diluent
SMN 10386994 REF
LPSZ

Class C
Shelf Life: 12 Months

42. -do- Legal Manufacturer/ Immulite 1000 PSA Prostate- Approved.

Manufacturing Site: Assay Specific
Evaluator: M/s Siemens Healthcare Antigen Assay
Muhammad Diagnostics Products i) Immulite 1000 PSA
Ayub Naveed Limited, Glyn Rhonwy, Assay
Llanberis, Caernarfon, SMN 10380960 REF
LL55 4EL, UK LKPS1 (100 Tests)
SMN 10380949 REF
(FSC UK Valid Till LKPS5 (500 Test)
16-10-2020)
Fee Submitted ii) Immulite PSA
Rs.50,000/- Sample Diluent
SMN 10386994 REF
LPSZ

Class C
Shelf Life: 12 Months
43. -do- Legal Manufacturer/ Atellica IM Toxoplasma IgM Approved.
Manufacturing Site: IgM (Toxo M) Assay Antibodies to
53
 Evaluator: Siemens Healthcare Toxoplasma
Muhammad Diagnostics Inc. located i) Atellica IM gondii Assay
Ayub Naveed at 511 Benedict Ave. Toxoplasma IgM (Toxo Group
Tarrytown, NY 10591, M)
USA SMN 10995701

(FSC UK Valid Till ii) Atellica IM

16-10-2020) Toxoplasma IgM
Quality Contorl (Toxo
Fee Submitted M QC)
Rs.50,000/- SMN 10995702

Class C
Shelf Life: 8 Months

44. -do- Legal Manufacturer/ Advia Centaur PSA Prostate- Approved.

Manufacturing Site: Assay Specific
Evaluator: Siemens Healthcare Antigen Assay
Muhammad Diagnostics Inc. located i) Advia Centaur PSA
Ayub Naveed at 511 Benedict Ave. Assay
Tarrytown, NY 10591, SMN 10310295 REF
USA 02484801 P/N 118220
SMN 10310296 REF
(FSC UK Valid Till 04847308 P/N 118221
16-10-2020)
ii) Advia Centaur
Fee Submitted Calibrator Q
Rs.50,000/- SMN 10310292 REF
06574155 P/N 118156
SMN 10310293 REF
02676506 P/N 118157

iii) ADVIA Centaur

Multi-Diluent 2
SMN 10309943 REF
07948423 P/N 110314
SMN 10311601 REF
04855629 P/N
672260000

Class C
Shelf Life: 12 Months

45. -do- Legal Manufacturer/ Advia Centaur Rubella IgM Approved.

Manufacturing Site: M Assay Antibodies to
Evaluator: Siemens Healthcare the Rubella
Muhammad Diagnostics Inc. located i) Advia Centaur Virus Group
Ayub Naveed at 511 Benedict Ave. Rubella M Assay
Tarrytown, NY 10591, SMN 10310285 REF
USA 02633319 P/N 117733
ii) Advia Centaur
(FSC UK Valid Till Rubella IgM QC
54
 16-10-2020) SMN 10310286 REF
00347629 P/N 117734
Fee Submitted
Rs.50,000/- Class C
Shelf Life: 12 Months

46. -do- Legal Manufacturer/ Advia Centaur Rubella IgM Approved.

Manufacturing Site: G Assay Antibodies to
Evaluator: Siemens Healthcare the Rubella
Muhammad Diagnostics Inc. located i) Advia Centaur Virus Group
Ayub Naveed at 511 Benedict Ave. Rubella G Assay
Tarrytown, NY 10591, SMN 10310283 REF
USA 08666235 P/N 117710

(FSC UK Valid Till ii) Advia Centaur

16-10-2020) Rubella G Quality
Control Material
Fee Submitted SMN 10310284 REF
Rs.50,000/- 01549403 P/N 117711

Class C
Shelf Life: 12 Months

47. -do- Legal Manufacturer/ Advia Centaur IgM Approved.

Manufacturing Site: Toxoplasma M Assay Antibodies to
Evaluator: Siemens Healthcare the
Muhammad Diagnostics Inc. located i) Advia Centaur Toxoplasma
Ayub Naveed at 511 Benedict Ave. Toxoplasma M Assay gondii Assay
Tarrytown, NY 10591, SMN 10310320 REF Group
USA 05303018 P/N 120153

(FSC UK Valid Till ii) Advia Centaur

16-10-2020) Toxoplasma M Quality
Control Material
Fee Submitted SMN 10310326 REF
Rs.50,000/- 03089388 P/N 120383

Class C
Shelf Life: 8 Months

48. -do- Legal Manufacturer/ Atellica IM Rubella IgG IgM Approved.

Manufacturing Site: (Rub G) Assay Antibodies to
Evaluator: Siemens Healthcare the Rubella
Muhammad Diagnostics Inc. located i) Atellica IM Rubella Virus Group
Ayub Naveed at 511 Benedict Ave. IgG (Rub G) Assay
Tarrytown, NY 10591, SMN 10995670
USA
ii) Atellica IM Rubella
(FSC UK Valid Till IgG Quality Control
16-10-2020) (Rub G QC)
SMN 10995671
55
 Fee Submitted
Rs.50,000/- Class C
Shelf Life: 12 Months

49. -do- Legal Manufacturer/ Atellica IM Toxoplasma IgM Approved.

Manufacturing Site: IgG (Toxo G) Antibodies to
Evaluator: Siemens Healthcare Toxoplasma
Muhammad Diagnostics Inc. located i) Atellica IM gondii Assay
Ayub Naveed at 511 Benedict Ave. Toxoplasma IgG (Toxo Group
Tarrytown, NY 10591, G)
USA SMN 10995699
ii) Atellica IM
(FSC UK Valid Till Toxoplasma IgM
16-10-2020) Quality Contorl (Toxo
M QC)
Fee Submitted SMN 10995702
Rs.50,000/-
Class C
Shelf Life: 12 Months

50. -do- Legal Manufacturer/ Atellica IM Rubella IgM IgM Approved.

Manufacturing Site: Assay Antibodies to
Evaluator: Siemens Healthcare the Rubella
Muhammad Diagnostics Inc. located i) Atellica IM Rubella Virus Group
Ayub Naveed at 511 Benedict Ave. IgM Assay
Tarrytown, NY 10591, SMN 10995668
USA
ii) Atellica IM Rubella
(FSC UK Valid Till IgM Quality Control
16-10-2020) (Rub M QC)
SMN 10995669
Fee Submitted
Rs.50,000/- Class C
Shelf Life: 12 Months
51. -do- Legal Manufacturer/ Siemens Advia Centaur An IVD Approved.
M/s Siemens Healthcare Toxoplasma G Assay immuno assay
Evaluator: Diagnostics Inc. Kit intended for
Unum Zia 511 Benedict Ave. the
Shamsi Tarrytown, NY 10591, 1. Advia Centaur quantitative
USA. Toxoplasma G and qualitative
detection of
Manufacturing Site: SMN 10310321 REF IgG antibodies
Siemens Healthcare 04520287 P/N 120154 to Toxoplasma
Diagnostics Inc. gondi in serum
333 Coney Street E. 2. Advia Centaur or plasma
Walpole, MA, 02032- Toxoplasma G Quality using ADVIA
1597 USA. Control Material Centaur,
ADVIA
(FSC UK Valid Till 31-12- SMN 10310325 REF Centaur XP
2020) 06317233 P/N 120382 and ADVIA
Fee Submitted Centaur XPT
Rs.50,000/- Class C systems.
56
 Shelf Life: 12 Months

52. -do- Legal Manufacturer/ Siemens Atellica IM In vitro Approved.

M/s Siemens Healthcare PSA Assay Kit diagnostic
Evaluator: Diagnostics Inc. assay intended
Unum Zia 511 Benedict Ave. 1. Siemens Atellica IM to
Shamsi Tarrytown, NY 10591, Prostate-Specific quantitatively
USA. Antigen (PSA) measure PSA
SMN10995662 (100 in Human
Manufacturing Site: tests) Serum using
Siemens Healthcare the Atellica IM
Diagnostics Inc. 2. Siemens Atellica IM systems.
333 Coney Street E. Prostate-Specific
Walpole, MA, 02032- Antigen (PSA)
1597 USA. SMN10995663 (500
tests)
(FSC UK Valid Till 31-12-
2020) 3. Siemens Atellica IM
Fee Submitted Calibrator (Cal Q)
Rs.50,000/- SMN10995517 ( 2
Packs)

4. Siemens Atellica IM
Calibrator (Cal Q)
SNM 10995518 (6
Packs)

5. Siemsens Atellica IM
Multi-Diluent 2
SMN 10995644

Class C

Shelf Life: 12 Months

53. M/s Cardiac Legal Manufacturer/ Arterial Leadercath Arterial Approved

Care Manufacturing Site: Class D Catheter for subject to
848-C, Shadman M/s VYGON 5 rue pressure provision of
1, Lahore Adeline, 95440 Ecouen, Shelf Life: 5 Years Measurement complete
France stability
(ELI-00070) 115 studies.
(FSC France Issuance 090/092/096/11/118/6
Evaluator: Date 10/698/710/798
Muhammad 13-06-2018)
Ayub Naveed
Fee Submitted
Rs.50,000/-

54. -do- Manufacturer: SKIPPER STERILE Oxygenator. Approved.

M/s. EUROSETS s.r.l, (OXYGENATORS)
Evaluator: Via Strada Statale 12,
57
 Muhammad n.143 EU5007 SKIPPER
Ayub Naveed 41036 Medolla (MO) STERILE
ITALY.
Class B
FSC Italy Shelf Life : 03 years
Issued on March 23,
2018.

Fee Submitted
Rs.50,000/-

55. -do- Manufacturer: Everest Titanium Hemostatic Approved.

M/s. MDD Medical Ligating Clip, Ligating Clips
Evaluator: Device Development (Ligating Clips)
Muhammad GmbH Steigacker 20,
Ayub Naveed 78582 Balgheim / Everest titanium
Germany. ligating clip small. 30
Cartridges of 6 clips
FSC Germany (red)
Issued on 20.02.2018. EVC 010
Everest titanium
Fee Submitted ligating clip medium 30
Rs.50,000/- Cartridges of 6 clips
(blue)
EVC020
Everest titianium
ligating clip medium/
large. 20 Cartridges of 6
clips (green)
EVC O30
Everest titanium
ligating clip large. 20
Cartridges of 6 clips
(orange)
EVC 040

Class : D
Shelf Life : 05 years

56. -do- Manufacturer: Technowood SoftNAV angiographic Approved.

M/s. Technowood Catheter Catheter
Evaluator: Corporation, 30-19 (Angiography, Central
Muhammad Kohoku, Adachi-ku, Catheter)
Ayub Naveed Tokyo, Japan.
Class : D
FSC Japan Shelf Life : 03 years
Issued on 30.10.2018.
FL:4FR
H710-FL418, H710-
Fee Submitted FL420, H710-FL422,
Rs.50,000/- H710-FL419, H710-
FL421, H710-FL423,
58
H710-FL418JSH , H710-
FL420JSH, H710-
FL422JSH , H710-
FL419JSH,
H710-FL421JSH , H710-
FL423JSH,  H710-
FL4060, H710-FL4013,
H710-FL4012,
H710-FL4011, H710-
FL4361, H710-FL4363,
H710-FL4362, H710-
FL4122,
H710-FL4123, H710-
FL445SH, H710-
FL446SH, H710-
FL401SH, H710-FL4601
H710-FL4711M,H710-
FL4713M, H710-
FL4731M, H710-
FL4733M,
H710-FL4741M, H710-
FL4743M, H710-
FL4751M, H710-
FL4753M

FL:5FR
H710-FL518, H710-
FL520, H710-FL522,
H710-FL519, H710-
FL521,
H710-FL523, H710-
FL518TJ, H710-FL520TJ,
H710-FL522TJ, H710-
FL519TJ,
H710-FL521TJ, H710-
FL523TJ, H710-FL5060,
H710-FL5013, H710-
FL5012,
H710-FL5011, H710-
FL5361, H710-FL5363,
H710-FL5362, H710-
FL5122,
H710-FL5123, H710-
FL545, H710-FL546,
H710-FL548, H710-
FL5601,
H710-FL5661, H710-
FL5662, H710-FL5671,
H710-FL5672, H710-
FL5307,
H710-FL5308, H710-
FL5309, H710-
59
FL5711M, H710-
FL5713M, H710-
FL5731M,
H710-FL5733M, H710-
FL5741M, H710-
FL5743M, H710-
FL5751M,
H710-FL5753M

SL-:4FR
H710-SL418, H710-
SL420, H710-SL422,
H710-SL419, H710-
SL421,
H710-SL423, H710-
SL418JSH, H710-
SL420JSH, H710-
SL422JSH,
H710-SL419JSH, H710-
SL421JSH, H710-
SL423JSH, SVH3-
SL418SH,
SVH3-SL420SH, SVH3-
SL419SH, SVH3-
SL421SH, H710-SL4060,
H710-SL4013,
H710-SL4012, H710-
SL4011, H710-SL4361,
H710-SL4363, H710-
SL4362,
H710-SL4122, H710-
SL4123, H710-SL445SH,
H710-SL446SH, H710-
SL401SH,
H710-FL4601, H710-
SL4711M, H710-
FL4713M, H710-
FL4731M,
H710-FL4733M, H710-
FL4741M, H710-
FL4743M, H710-
FL4751M,
H710-FL4753M

SL:5FR
H710-SL518, H710-
SL520, H710-SL522,
H710-SL519, H710-
SL521,
H710-SL523, H710-
SL518TJ, H710-SL520TJ,
H710-SL522TJ, H710-
60
SL519TJ,
H710-SL521TJ, H710-
SL523TJ, SVH3-
SL518SH, SVH3-
SL520SH, SVH3-
SL519SH,
SVH3-SL521SH, H710-
SL5060, H710-SL5013,
H710-SL5012, H710-
SL5011,
H710-SL5361, H710-
SL5363, H710-SL5362,
H710-SL5122, H710-
SL5123,
H710-S545, H710-S54,
H710-SL548, H710-
SL5601, H710-SL5661,
H710-SL5662, H710-
SL5671, H710-SL5672,
H710-SL5307, H710-
SL5308,
H710-SL5309, H710-
SL5711M, H710-
FL5713M, H710-
FL5731M,
H710-FL5733M, H710-
FL5741M, H710-
FL5743M, H710-
FL5751M,
H710-FL5753M

TIP SHAPE
JL 3.5, JL 4.0, JL 5.0, JR
3.5, JR 4.0, JR 5.0,
JL 3.5 MOD 2, JL 4.0
MOD 2, JL 5.0 MOD 2,
JL 3.5 MOD 2, JL 4.0
MOD 2,
JL 5.0 MOD 2, JL 3.5
SAFETY, JL 4.0
SAFETY, JL 3.5
SAFETY, JL 4.0
SAFETY,

KIMTAC 2
SAITO 3.0, SAITO 3.5,
SAITO 4.0, M-3 LR 3.0,
M-3 LR 3.5, M-3 LR 4.0,
Toranomon 3.5
Toranomon 4.0

AL 1, AL2, AR MOD,
61
 AR MOD, IM, Mpa 1
small, Mpa 1 small,
Mpa 1 small,
Mpa 1 small, Nishiya S,
Nishiya S, Nishiya S,
STRAIGHT,
STRAIGHT, ANGLE
145,
ANGLE 145, ANGLE
145, ANGLE 155,
MULTICURVE,
MULTICURVE
57. -do- Manufacturer: Technowood SSS Coronary Approved.
M/s. Technowood Guidewire Angiographic
Evaluator: Corporation, 4-30-19 (Catheter Guidewire) Guidewire.
Muhammad Kouhoku, adachi-ku
Ayub Naveed Tokyo, Japan. H502-3515S, H502-
3518S,
FSC Japan H502-3520S, H502-
Valid till March 7, 2020. 3522S
H502-3526S, H502-
Fee Submitted 3515A
Rs.50,000/- H502-3518A, H502-
3520A
H502-3522A, H502-
3526A
H502-3515P3, H502-
3518P3
H502-3520P3, H502-
3522P3
H502-3526P3, H502-
3515PK1.5
H502-3518PK1.5, H502-
3520PK1.5
H502-3522PK1.5, H502-
3526PK1.5
H502-3515BK2, H502-
3518BK2
H502-3520BK2, H502-
3522BK2
H502-3526BK2, H502-
3515AM
H502-3518AM, H502-
3520AM
H502-3522AM, H502-
3515S
H502-3518S, H502-
3520S
H502-3522S, H502-
3526S
H502-3515A, H502-
3518A
62
H502-3520A, H502-
3522A
H502-3526A, H502-
3515P3
H502-3518P3, H502-
3520P3
H502-3522P3, H502-
3526P3
H502-3515PK1.5, H502-
3518PK1.5
H502-3520PK1.5, H502-
3522PK1.5
H502-3526PK1.5, H502-
3515BK2
H502-3518BK2, H502-
3520BK2
H502-3522BK2, H502-
3526BK2
H502-3515AM, H502-
3518AM
H502-3520AM, H502-
3522AM
H503-3515S, H503-
3518S
H503-3520S, H503-
3522S
H503-3526S, H503-
3515A
H503-3518A, H503-
3520A
H503-3522A, H503-
3526A
H503-3515P3, H503-
3518P3
H503-3520P3, H503-
3522P3
H503-3526P3, H503-
3151BK1.5
H503-3518BK1.5, H503-
3520BK1.5
H503-3522BK1.5, H503-
3526BK1.5
H503-3515BK2, H503-
3518BK2
H503-3520BK2, H503-
3522BK2
H503-3526BK2, H503-
3515AM
H503-3518AM, H503-
3520AM
H503-3522AM, H503-
3526AM
63
 H503-3151BK1.5M
H503-3518BK1.5M
H503-3520BK1.5M
H503-3522BK1.5M
H503-3526BK1.5M
H503L-3515BK1.5M
H503L-3518BK1.5M
H503L-3520BK1.5M
H503L-3522BK1.5M
H503L-3526BK1.5M

Class : D
Shelf Life : 03 years
58. -do- Manufacturer: TRILLY STERILE Oxygenator. Approved.
M/s. Eurosets srl (OXYGENATORS)
Evaluator: STRADA STATALE 12,
Muhammad n.143 (EU5032)
Ayub Naveed 41036 MEDOLLA (MO)
ITALY. Class B
Shelf Life : 03 years.
FSC Italy Issued on
March 23, 2018.
Fee Submitted
Rs.50,000/-
59. -do- Manufacturer: On-X Aortic Prosthetic Aortic Heart Approved.
M/s. On-X Life Heart Valves Valve
Evaluator: Technologies, Inc. 1300 AORTIC HEART
Muhammad East, Anderson, Lane VALVE- Standard
Ayub Naveed Building B, Austin, Texas Sewing Ring
78752, USA 1)      ONXA-19
2)      ONXA-21
FSC USFDA 3)      ONXA-23
Valid till March 7, 2020. 4)      ONXA-25
5)      ONXA-27/29
Fee Submitted
Rs.50,000/- Class : D
Shelf Life : 06 years

60. M/s Allmed Manufactured By: BIP Foley Catheter BIP Foley Approved.
Solutions, A- M/s Bactiguard AB, (Latex) Catheter
21/3 KDA Alfred Nobels Alle 150,
Scheme 1 (Ext) 146 48 Tullinge, Sweden Class C
Opposite
Shelf Life: 5 Years
National (FSC Sweden Valid Till
Stadium Road, 01-10-2023) Pediatric 2-Way
Karachi Fr. 08, 10
Fee Submitted Adult 2-Way
(ELI-00029) Rs.50,000/- Fr. 12, 14, 16, 18, 20, 22,
24, 26, 28, 30
Evaluator: Adult 3-Way
Muhammad Fr. 16, 18, 20, 22, 24, 26,
Ayub Naveed
64
61. -do- Manufactured By: BIP Foley Catheter BIP Foley Approved.
M/s Bactiguard AB, (Silicone) Catheter
Evaluator: Alfred Nobels Alle 150,
Muhammad 146 48 Tullinge, Sweden Class C
Ayub Naveed
Shelf Life: 5 Years
(FSC Sweden Valid Till
01-10-2023) Pediatric 2-Way
Fr.6,8,10
Adult 2-Way
Rs.50,000/- already Fr. 12, 14, 16, 18, 20, 22,
submitted against Slip 24, 26,
No. 0012677 dated 29-11- Female 2-Way
2013 Fr. 12, 14, 16, 18, 20, 22,
24, 26,
Tiemann Tip 2-Way
Fr. 10, 12, 14, 16, 18, 20,
22, 24
Adult 3-Way
Fr. 16, 18, 20, 22, 24, 26,
Female 3-Way
Fr. 16, 18, 20, 22, 24, 26,
62. -do- Manufactured By: BIP Endotracheal Tube BIP Approved.
M/s Bactiguard AB, Endotracheal
Evaluator: Alfred Nobels Alle 150, Class C Tube
Hafiz 146 48 Tullinge, Sweden
Shelf Life: 5 Years
Muhammad Asif
Iqbal (FSC Sweden Valid Till 311003010 BIP
01-10-2023)
Endotracheal Tube ID
Fee Submitted 3.0
Rs.50,000/-
311003510 BIP
Endotracheal Tube ID
3.5
311004010 BIP
Endotracheal Tube ID
4,0
311004010 BIP
Endotracheal Tube ID
4,5
311004510 BIP
Endotracheal Tube ID
5,0
311005010 BIP
Endotracheal Tube ID

65
 5,5
311005510 BIP
Endotracheal Tube ID
6,0
311006010 BIP
Endotracheal Tube ID
6,5
311006510 BIP
Endotracheal Tube ID
7,0
311007010 BIP
Endotracheal Tube ID
7,5
311007510 BIP
Endotracheal Tube ID
8,0
311008010 BIP
Endotracheal Tube ID
8,5
311008510 BIP
Endotracheal Tube ID
9,0
311009010 BIP
Endotracheal Tube ID
9,5
311009510 BIP
Endotracheal Tube ID
10,0
311010010 BIP
Endotracheal Tube ID
63. M/s Life Cares, Manufactured By: Leader® Plus Cobalt Bare Metal Approved.
M-20, Mezzanine M/s Rontis Corporation Chromium Coronary Stent System
Floor Falaknaz S.A. Bahnhosfstrasse 7, Stent System
Plaza Natha CH-6301 Zug,
Khan Bridge, Switzerland Class D
Shahra-e-Faisal,
Shelf Life: 4 Years
Karachi (FSC Switzerland Valid

66
 Till 13-02-2021)
(ELI-00077)
Codes & Sizes as per
Fee Submitted
Evaluator: Rs.50,000/- FSC
Muhammad
Ayub Naveed
64. -do- Manufactured By: Europa Ultra TM Semi Catheter Approved.
M/s Rontis Corporation Compliant Coronary
Evaluator: S.A. Bahnhosfstrasse 7, Balloon Catheter
Muhammad CH-6301 Zug,
Ayub Naveed Switzerland Class D
Shelf Life: 4 Years
(FSC Switzerland Valid
Till 13-02-2021)

Fee Submitted
Rs.50,000/-

65. -do- Manufactured By: Lotus II TM 0.017 guidewire Approved.

M/s Rontis Corporation Coronary Guidewire
Evaluator: S.A. Bahnhosfstrasse 7,
Hafiz CH-6301 Zug, Class D
Muhammad Asif Switzerland
Shelf Life: 4 Years
Iqbal
(FSC Switzerland Valid Codes and sizes as per
Till 13-02-2021)
FSC
Fee Submitted
Rs.50,000/-

66. -do- Manufactured By: Abrax TM Sirolimus- Stent System Approved.

M/s Rontis Corporation Eluting Biodegradable
Evaluator: S.A. Bahnhosfstrasse 7, Polymer Coronary
Hafiz CH-6301 Zug, Stent System
Muhammad Asif Switzerland
Iqbal Class D
(FSC Switzerland Valid
Shelf Life: 24 Months
Till 13-02-2021)
Fee Submitted
Rs.50,000/-

67. M/s Ham Manufactured By: Shunmei PTFE coated PTFE coated Approved
International M/s Shunmei Medical Guide wire Guide wire subject to
Mezzanine Floor, Co., Ltd., R401 of submission
Plot No. LS 2, St Building B, No.8 Jinlong Class D of Pakistan
9, Block 15, KDA 1st Road, Baolong Embassy
Shelf Life: 3 Years
Scheme 36, Industrial Zone, Long attested FSC
Gulistan Johar, Gang District, Shenzhen, Codes & Sizes codes as from UK.
Karachi China
per FSC.
(ELI-00008) (FSC UK Issuance Date
20-04-2017)
67
 Evaluator:
Muhammad Fee Submitted
Ayub Naveed Rs.50,000/-

68. M/s. Treu- Legal manufacturer Genutech Total Knee Total Knee The Board
Dynamic Replacement system Prosthesis. referred the
International. M/s. SURGIVAL Co. matter to Dr.
C-206, 2nd Floor S.A.U Class C Khalid S.
city Towers, C/Leonardo da Vinci 12- Shelf Life : 05 years Aslam,
Main Boulevard, 14 46980 Components of Orthopaedic
Gulberg, Lahore. Paterna (Valencia) Spain. system: Surgeon,
Codes & Sizes as per Quaid-e-
(ELI-00175) FSC Spain FSC No. 16/2018 of Azam
Issued on March 14, 2018 Spain International
Evaluator: Hospital for
Muhammad Rs. 50,000 opinion
Ayub Naveed  PS Cemented whether in
Femoral international
Component practice the
 NPS Cemented product
Femoral under
Component consideration
 Revision Cemented is supplied
Femoral sterile or are
Component sterilized in
 PS Cementless the hospital
Femoral before
Component surgery.
 NPS Cementless Secondly the
Femoral components
Component mentioned
 PS Tibial insert can be
 NPS Tibial insert grouped
together as
 Revision Tibial
one system to
insert
be used in
 Tibial Tray
surgery.
 Revision Tibial
Tray.
 Patellar Component
 Offset Revision
Stem.
 Straight Revision
Stem.
 Posterior Femoral
supplement
 Distal Femoral
supplement
 Tibial supplement

69. -do- Legal manufacturer Total Hip Replacement The total hip The Board
68
 System. replacement referred the
Evaluator: M/s. SURGIVAL Co. System is matter to Dr.
Muhammad S.A.U Class C Group of Khalid S.
Ayub Naveed Leonardo da Vinci 12-14 Shelf Life: 05 years Medical Aslam,
46980 Devices used Orthopaedic
Paterna (Valencia) Spain. Consist on the as System Surgeon,
following under the Quaid-e-
FSC Spain components :- name of the Azam
Issued on March 14, 2018 1. SELF-LOCKING total Hip International
STEM, replacement Hospital for
Nitrogen S.S SELF- system. opinion
Rs. 50,000 LOCKING STEM 12/14 whether in
6.25 mm international
(A1501009E) practice the
Nitrogen S.S SELF- product
LOCKING STEM 12/14 under
7.5 mm consideration
(A1501010E) is supplied
Nitrogen S.S SELF- sterile or are
LOCKING STEM 12/14 sterilized in
10.0 mm the hospital
(A1501020E) before
Nitrogen S.S SELF- surgery.
LOCKING STEM 12/14 Secondly the
11.25 mm components
(A1501021E) mentioned
Nitrogen S.S SELF- can be
LOCKING STEM 12/14 grouped
12.50 mm together as
(A1501030E) one system to
Nitrogen S.S SELF- be used in
LOCKING STEM 12/14 surgery.
13.75 mm
(A1501031E)
Nitrogen S.S SELF-
LOCKING STEM 12/14
15.00 mm
(A1501040E)
17.50 mm
(A1500014E)
Titanium SELF-
LOCKING STEM 12/14
6.25 mm , TPS
Cementless
(A1502010E)
Titanium SELF-
LOCKING STEM 12/14
7. 50 mm , TPS
Cementless
(A1502011E)
Titanium SELF-
LOCKING STEM 12/14
69
10. 00 mm , TPS
Cementless
(A1502012E)
Titanium SELF-
LOCKING STEM 12/14
11. 25 mm , TPS
Cementless
(A1502112E)
Titanium SELF-
LOCKING STEM 12/14
12. 50 mm , TPS
Cementless
(A1502013E)
TitaniumSELF-
LOCKING STEM 12/14
13.75 mm TPS
Cementless
(A1502113E)
TitaniumSELF-
LOCKING STEM12/14
15.00 mm TPS
Cementless
(A1502014E)
Titanium SELF-
LOCKING STEM 12/14
17.50 mm TPS
Cementless
(A1502015E)
Titanium SELF-
LOCKING STEM 12/14
6.25 mm , HA
Cementless
(A1504010E)
Titanium SELF-
LOCKING STEM 12/14
7. 50 mm , HA
Cementless
(A1504011E)
Titanium SELF-
LOCKING STEM 12/14
10. 00 mm , HA
Cementless
(A1504012E)
Titanium SELF-
LOCKING STEM 12/14
11. 25 mm , HA
Cementless
(A1504112E)
Titanium SELF-
LOCKING STEM 12/14
12. 50 mm , HA
Cementless
70
(A1504013E)
TitaniumSELF-
LOCKING STEM12/14
13.75 mm HA
Cementless
(A1504113E)
TitaniumSELF-
LOCKING STEM 12/14
15.00 mm HA
Cementless
(A1504014E)
Titanium SELF-
LOCKING STEM 12/14
17.50 mm HA
Cementless
(A1504015E)
Titanium Karey-C
Femoral Stem
Cemented 12/14No. 9
(F0005109E)
Titanium Karey-C
Femoral Stem
Cemented 12/14 No. 10
(F0005110E)
Titanium Karey-C
Femoral Stem
Cemented 12/14 No. 11
(F0005111E)
Titanium Karey-C
Femoral Stem
Cemented 12/14 No. 12
(F0005112E)
Titanium Karey-C
Femoral Stem
Cemented 12/14 No. 13
(F0005113E)

Titanium Karey-C
Femoral Stem
Cemented 12/14 No. 14
(F0005114E)
Titanium Karey-C
Femoral Stem
Cemented 12/14 No. 15
(F0005115E)
Titanium Karey-C
Femoral Stem
Cemented 12/14 No. 16
(F0005116E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 8
71
(F0005158E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 9
(F0005159E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 10
(F0005160E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 11
(F0005161E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 12
(F0005162E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 13
(F0005163E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 14
(F0005164E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 15
(F0005165E)
High Nitrogen S.S
Karey-C Femoral Stem
Cemented 12/14 No. 16
(F0005166E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No. 8
(F0005008E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No. 9
(F0005009E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No.
10
(F0005010E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No.
11
(F0005011E)
Titanium Karey-HA
72
Femoral Stem
Cementless 12/14 No.
12
(F0005012E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No.
13
(F0005013E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No.
14
(F0005014E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No.
15
(F0005015E)
Titanium Karey-HA
Femoral Stem
Cementless 12/14 No.
16
(F0005016E)
Titanium Karey-
Revision HA Femoral
Stem Cementless 12/14
No.12 (F0005412E)
Titanium Karey-
Revision HA Femoral
Stem Cementless 12/14
No.14 (F0005414E)
Titanium Karey-
Revision HA Femoral
Stem Cementless 12/14
No.16 (F0005416E)
Titanium Karey-
Revision HA Femoral
Stem Cementless 12/14
No.18 (F0005418E)
Titanium Karey-
Revision C Femoral
Stem Cemented 12/14
No. 12 (F0005452E)
Titanium Karey-
Revision C Femoral
Stem Cemented 12/14
No. 14 (F0005454E)
Titanium Karey-
Revision C Femoral
Stem Cemented 12/14
No. 16 (F0005456E)
73
Titanium Karey-
Revision C Femoral
Stem Cemented 12/14
No. 18 (F0005458E)
Titanium Karey-
Revision C Femoral
Stem Cemented 12/14
No. 20 (F0005460E)
Nitrogen S.S Shine-C
Femoral Stem
Cemented 12/14 No. 0
(A2700000E)
Nitrogen S.S Shine-C
Femoral Stem
Cemented 12/14 No. 1
(A2700001E)
Nitrogen S.S Shine-C
Femoral Stem
Cemented 12/14 No. 2
(A2700002E)
Nitrogen S.S Shine-C
Femoral Stem
Cemented 12/14 No. 3
(A2700003E)
Nitrogen S.S Shine-C
Femoral Stem
Cemented 12/14 No. 4
(A2700004E)

2. Femoral Head

Stainless Steel
Endocephalic Femoral
Head, 12/14 38 mm
(A1513238E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 39 mm
(A1513239E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 40 mm
(A1513240E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 41 mm
(A1513241E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 42 mm
(A1513242E)
Stainless Steel
74
Endocephalic Femoral
Head, 12/14 43 mm
(A1513243E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 44 mm
(A1513244E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 45 mm
(A1513245E)

Stainless Steel
Endocephalic Femoral
Head, 12/14 46 mm
(A1513246E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 47 mm
(A1513247E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 48 mm
(A1513248E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 49 mm
(A1513249E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 50 mm
(A1513250E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 51 mm
(A1513251E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 52 mm
(A1513252E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 53 mm
(A1513253E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 54 mm
(A1513254E)
Stainless Steel
Endocephalic Femoral
Head, 12/14 55 mm
(A1513255E)
75
Stainless Steel
Endocephalic Femoral
Head, 12/14 56 mm
(A1513256E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 38 mm
(A1513338E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 39 mm
(A1513339E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 40 mm
(A1513340E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 41 mm
(A1513341E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 42 mm
(A1513342E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 43 mm
(A1513343E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 44 mm
(A1513344E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 45 mm
(A1513345E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 46 mm
(A1513346E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 47 mm
(A1513347E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 48 mm
(A1513348E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 49 mm
(A1513349E)
76
Stainless Steel
Endocephalic Femoral
Head, Neck-5 50 mm
(A1513350E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 51 mm
(A1513351E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 52 mm
(A1513352E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 53 mm
(A1513353E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 54 mm
(A1513354E)
Stainless Steel
Endocephalic Femoral
Head, Neck-5 55 mm
(A1513355E)
Stainless Steel Femoral
Head 12/14, Short
Neck 22 mm
(A1509060E)
Stainless Steel Femoral
Head 12/14, Short
Neck 26 mm
(A1509050E)
Stainless Steel Femoral
Head 12/14, Short
Neck 28 mm
(A1509040E)
Stainless Steel Femoral
Head 12/14, Short
Neck 32 mm
(A1509013E)
Stainless Steel Femoral
Head 12/14, Medium
Neck 22 mm
(A1509061E)
Stainless Steel Femoral
Head 12/14, Medium
Neck 26 mm
(A1509051E)
Stainless Steel Femoral
Head 12/14, Medium
Neck 28 mm
(A1509041E)
77
Stainless Steel Femoral
Head 12/14, Medium
Neck 32 mm
(A1509014E)
Stainless Steel Femoral
Head 12/14, Long
Neck 22 mm
(A1509062E)
Stainless Steel Femoral
Head 12/14, Long
Neck 26 mm
(A1509052E)
Stainless Steel Femoral
Head 12/14, Long
Neck 28 mm
(A1509042E)
Stainless Steel Femoral
Head 12/14, Long
Neck 32 mm
(A1509015E)
Stainless Steel Femoral
Head 12/14, Extra
Long Neck 26 mm
(A1509053E)
Stainless Steel Femoral
Head 12/14, Extra Long
Neck 28 mm
(A1509043E)
Alumina Ceramic
Femoral Head 12/14,
Short Neck 26 mm
(A1507050E)
Alumina Ceramic
Femoral Head 12/14,
Short Neck 28 mm
(A1507040E)
Alumina Ceramic
Femoral Head 12/14,
Medium Neck 26 mm
(A1507051E)
Alumina Ceramic
Femoral Head 12/14,
Medium Neck 28 mm
(A1507041E)
Alumina Ceramic
Femoral Head 12/14,
Long Neck 26 mm
(A1507052E)
Alumina Ceramic
Femoral Head 12/14,
Long Neck 28 mm
(A1507042E)
78
CrCoMo Femoral Head
12/14, Short Neck 22
mm
(A1506060E)
CrCoMo Femoral Head
12/14, Short Neck 26
mm
(A1506050E)
CrCoMo Femoral Head
12/14, Short Neck 28
mm
(A1506040E)
CrCoMo Femoral Head
12/14,Medium Neck
22 mm
(A1506061E)
CrCoMo Femoral Head
12/14, Medium Neck
26 mm
(A1506051E)
CrCoMo Femoral Head
12/14, Medium Neck
28 mm
(A1506041E)
CrCoMo Femoral Head
12/14,Long Neck 22
mm
(A1506062E)
CrCoMo Femoral Head
12/14, Long Neck 26
mm
(A1506052E)
CrCoMo Femoral Head
12/14, Long Neck 28
mm
(A1506042E)
CrCoMo Femoral Head
12/14, Extra Long
Neck 26 mm
(A1506053E)
CrCoMo Femoral Head
12/14, Extra Long
Neck 28 mm
(A1506043E)
Stainless Steel
Biarticular Head 41
mm
(A1519041E)
Stainless Steel
Biarticular Head 42
mm
(A1519042E)
79
Stainless Steel
Biarticular Head 43
mm
(A1519043E)
Stainless Steel
Biarticular Head 44
mm
(A1519044E)
Stainless Steel
Biarticular Head 45
mm
(A1519045E)
Stainless Steel
Biarticular Head 46
mm
(A1519046E)
Stainless Steel
Biarticular Head 47
mm
(A1519047E)

Stainless Steel
Biarticular Head 48
mm
(A1519048E)
Stainless Steel
Biarticular Head 49
mm
(A1519049E)
Stainless Steel
Biarticular Head 50
mm
(A1519050E)
Stainless Steel
Biarticular Head 51
mm
(A1519051E)
Stainless Steel
Biarticular Head 52
mm
(A1519052E)
Stainless Steel
Biarticular Head 53
mm
(A1519053E)
Stainless Steel
Biarticular Head 54
mm
(A1519054E)
Stainless Steel
Biarticular Head 55
mm
80
(A1519055E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 28
mm
A ( 41,42,43 mm )
(A1519141E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 28
mm
B ( 44,45,46 mm )
(A1519144E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 28
mm
C ( 47,48,49,50 mm )
(A1519147E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 28
mm
D ( 51,52,53,54,55 mm )
(A1519151E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 22
mm
A ( 41,42,43 mm )
(A1519241E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 22
mm
B ( 44,45,46 mm )
(A1519244E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 22
mm
C ( 47,48,49,50 mm )
(A1519247E)
Biarticular Head
Polyethylene
(UHMWPE) Insert 22
mm
D ( 51,52,53,54,55 mm )
(A1519251E)

3. Acetabular Cup

81
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 40 x
28 mm (A1512240E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 42 x
28 mm
(A1512242E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 44 x
28 mm
(A1512244E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 46 x
28 mm
(A1512246E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 48 x
28 mm
(A1512248E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 50 x
28 mm
(A1512250E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 52 x
28 mm
(A1512252E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
82
Muller Cemented 54 x
28 mm
(A1512254E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 56 x
28 mm
(A1512256E)
Polyethylene
(UHMWPE)
Antiluxation
Acetabular Cup Type
Muller Cemented 58 x
28 mm
(A1512258E)
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite
(HA)Cementless 46
mm (A2400646E)
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite (HA)
Cementless 48 mm
(A2400648E)
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite (HA)
Cementless 50 mm
(A2400650E)
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite (HA)
Cementless 52 mm
(A2400652E)
Titanium S.H.Y+ TI
Plasma Spray (TPS) +H
hidroxiapatite (HA)
Cementless 54 mm
(A2400654E)
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite (HA)
Cementless 56 mm
(A2400656E)
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite (HA)
Cementless 58 mm
(A2400658E)
83
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite (HA)
Cementless 60 mm
(A2400660E)
Titanium S.H.Y+ TI
Plasma Spray (TPS)
+Hidroxiapatite (HA)
Cementless 62 mm
(A2400662E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE) 46 x 26
mm
(A2400746E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 48 x 26
mm
(A2400748E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 46 x 26
mm
(A2400746E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 50 x 28
mm
(A2400750E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 52 x 28
mm
(A2400752E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 54 x 28
mm
(A2400754E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 56 x 28
mm
(A2400756E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 58 x 28
mm
(A2400758E)
S.H.Y Cup
Polyethylene Insert
84
(UHMWPE ) 60 x 28
mm
(A2400760E)
S.H.Y Cup
Polyethylene Insert
(UHMWPE ) 62 x 28
mm
(A2400762E)
Cementless Quarter
Cup Titanium 40 mm
(A2401640E)
Cementless Quarter
Cup Titanium 42 mm
(A2401642E)
Cementless Quarter
Cup Titanium 44 mm
(A2401644E)
Cementless Quarter
Cup Titanium 46 mm
(A2401646E)
Cementless Quarter
Cup Titanium 48 mm
(A2401648E)
Cementless Quarter
Cup Titanium 50 mm
(A2401650E)
Cementless Quarter
Cup Titanium 52 mm
(A2401652E)
Cementless Quarter
Cup Titanium 54 mm
(A2401654E)
Cementless Quarter
Cup Titanium 56 mm
(A2401656E)
Cementless Quarter
Cup Titanium 58 mm
(A2401658E)
Cementless Quarter
Cup Titanium 60 mm
(A2401660E)
Cementless Quarter
Cup Titanium 62 mm
(A2401662E)
Cementless Quarter
Cup Titanium 64 mm
(A2401664E)
Cementless Quarter
Cup Titanium 66 mm
(A2401666E)
Cementless Quarter
Cup Titanium 68 mm
85
(A2401668E)
Quarter
InsertAntiluxation 40
x22 mm (A2412240E)
Quarter Insert
Antiluxation 42 x22 mm
(A2412242E)
Quarter Insert
Antiluxation 44x22 mm
(A2412244E)
Quarter Insert
Antiluxation 46x22 mm
(A2412246E)
Quarter Insert
Antiluxation 44x28 mm
(A2412844E)
Quarter Insert
Antiluxation 46x28 mm
(A2412846E)
Quarter Insert
Antiluxation 48x28 mm
(A2412848E)
Quarter Insert
Antiluxation 50x28 mm
(A2412850E)
Quarter Insert
Antiluxation 52x28 mm
(A2412852E)
Quarter Insert
Antiluxation 54x28 mm
(A2412854E)
Quarter Insert
Antiluxation 56x28 mm
(A2412856E)
Quarter Insert
Antiluxation 58x28 mm
(A2412858E)
Quarter Insert
Antiluxation 60x28 mm
(A2412860E)
Quarter Insert
Antiluxation 62x28 mm
(A2412862E)
Quarter Insert
Antiluxation 64x28 mm
(A2412864E)
Quarter Insert
Antiluxation 66x28 mm
(A2412866E)
Quarter Insert
Antiluxation 68x28 mm
(A2412868E)
86
Quarter Insert
Antiluxation 48x32 mm
(A2413248E)
Quarter Insert
Antiluxation 50x32 mm
(A2413250E)
Quarter Insert
Antiluxation 52x32 mm
(A2413252E)
Quarter Insert
Antiluxation 54x32 mm
(A2413254E)
Quarter Insert
Antiluxation 56x32 mm
(A2413256E)
Quarter Insert
Antiluxation 58x32 mm
(A2413258E)
Quarter Insert
Antiluxation 60x32 mm
(A2413260E)
Quarter Insert
Antiluxation 62x32 mm
(A2413262E)
Quarter Insert
Antiluxation 64x32 mm
(A2413264E)
Quarter Insert
Antiluxation 66x32 mm
(A2413266E)
Quarter Insert
Antiluxation 68x32 mm
(A2413268E)
Quarter Insert
Antiluxation 52x36 mm
(A2413652E)
Quarter Insert
Antiluxation 54x36 mm
(A2413654E)
Quarter Insert
Antiluxation 56x36 mm
(A2413656E)
Quarter Insert
Antiluxation 58x36 mm
(A2413658E)
Quarter Insert
Antiluxation 60x36 mm
(A2413660E)
Quarter Insert
Antiluxation 62x36 mm
(A2413662E)
Quarter Insert
87
Antiluxation 64x36 mm
(A2413664E)
Quarter Insert
Antiluxation 66x36 mm
(A2413666E)
Quarter Insert
Antiluxation 68x36 mm
(A2413668E)
Quarter Insert Neutral
44x28 mm
(A2402844E)
Quarter Insert Neutral
46x28 mm
(A2402846E)
Quarter Insert Neutral
48x28 mm
(A2402848E)
Quarter Insert Neutral
50x28 mm
(A2402850E)
Quarter Insert Neutral
52x28 mm
(A2402852E)
Quarter Insert Neutral
54x28 mm
(A2402854E)
Quarter Insert Neutral
56x28 mm
(A2402856E)
Quarter Insert Neutral
58x28 mm
(A2402858E)
Quarter Insert Neutral
60x28 mm
(A2402860E)
Quarter Insert Neutral
62x28 mm
(A2402862E)
Quarter Insert Neutral
64x28 mm
(A2402864E)
Quarter Insert Neutral
66x28 mm
(A2402866E)
Quarter Insert Neutral
68x28 mm
(A2402868E)
Quarter Insert Neutral
48x32 mm
(A2403248E)
Quarter Insert Neutral
50x32 mm
88
(A2403250E)
Quarter Insert Neutral
52x32 mm
(A2403252E)
Quarter Insert Neutral
54x32 mm
(A2403254E)
Quarter Insert Neutral
56x32 mm
(A2403256E)
Quarter Insert Neutral
58x32 mm
(A2403258E)
Quarter Insert Neutral
60x32 mm
(A2403260E)
Quarter Insert Neutral
62x32 mm
(A2403262E)
Quarter Insert Neutral
64x32 mm
(A2403264E)
Quarter Insert Neutral
66x32 mm
(A2403266E)
Quarter Insert
Neutral68x32 mm
(A2403268E)
Quarter Insert Neutral
52x36 mm
(A2403652E)
Quarter Insert Neutral
54x36 mm
(A2403654E)
Quarter Insert Neutral
56x36 mm
(A2403656E)
Quarter Insert Neutral
58x36 mm
(A2403658E)
Quarter Insert Neutral
60x36 mm
(A2403660E)
Quarter Insert Neutral
62x36 mm
(A2403662E)
Quarter Insert Neutral
64x36 mm
(A2403664E)
Quarter Insert Neutral
66x36 mm
(A2403666E)
89
 Quarter Insert Neutral
68x36 mm
(A2403668E)
Quarter Insert Neutral
56x40 mm
(A2404056E)
Quarter Insert Neutral
58x40 mm
(A2404058E)
Quarter Insert Neutral
60x40 mm
(A2404060E)
Quarter Insert Neutral
62x40 mm
(A2404062E)
Quarter Insert Neutral
64x40 mm
(A2404064E)
Quarter Insert Neutral
66x40 mm
(A2404066E)
Quarter Insert Neutral
68x40 mm
(A2404068E)

4. Screw for Cup

SHY Screw for Cup L=

20 mm
(A2400520)
SHY Screw for Cup L=
25 mm
(A2400525)
SHY Screw for Cup L=
30 mm
(A2400530)
SHY Screw for Cup L=
35 mm
(A2400535)
SHY Screw for Cup L=
40 mm
(A2400540)
SHY Screw for Cup L=
45 mm
(A2400545)

70. -do- Legal manufacturer Anterior Spinal Botec The Board

M/s. Wuxi BoTEC fixation System Osteosynthesis referred the
Evaluator: Medical Innovation Co., System matter to Dr.
Muhammad Ltd. OSTEOSYNTHESİS Description of Khalid S.
Ayub Naveed No. 8-9 Jingrui Rd, SYSTEM.having Device, Aslam,
90
 Zhangjing, Xibei Town, following parts Presentation Orthopaedic
Xishan Area, Wuxi, PINE ROD form and List Surgeon,
Jiangsu Province, 214194 PINE FIXED AXIAL of Instruments Quaid-e-
P.R. China SCREW used to Azam
PINE MULTI AXIAL implant the International
FSC Germany SCREW Device. Hospital for
Issued on 01.10.2018 PINE MULTI AXIAL The Botec opinion
Reduction SCREW Osteosynthesis whether in
Fee Submitted PINE SET SCREWw Implants international
Rs.50,000/- PINE CROSS LINK Group of practice the
Hopper Plates, Screw Medical product
set Devices used under
Eagle Plates, screw set as System. consideration
Octopus plates, screw The Botec is supplied
set Spinal System sterile or are
Leopard Plates, Screw consists sterilized in
set mainly of three the hospital
Rhino Plates, Screw set key elements: before
Double thread Screws the Spinal surgery.
Hummer Screws Screw (Fixed Secondly the
DORADO Wire. Head, components
Multiaxial, mentioned
Class D and can be
Shelf Life : 05 years Reduction), grouped
Titanium Rod, together as
and Cross one system to
Link. be used in
surgery.
71. M/s. Pak Punjab Legal manufacturer DESyne X2 NECSS Novolimus Approved.
Cardex Medical M/s. Elixir Medical Novolimus Drug Drug Eluting
System, R-202, Corporation, 920N.McC Eluting Stent System Stent System
eden Height Jail Arthy Blvd., Suite 100
Road, Lahore. Milpitas CA 95035 USA. SZR2514, SZR2518
SZR2523, SZR2528
ELI-00174 Authorized SZR2532, SZR2538
Representative SZR2714, SZR2718
Evaluator: M/s. Acorn Regulatory SZR2723, SZR2728
Muhammad Consultancy Services SZR2732, SZR2738
Ayub Naveed Ltd., Knockmorris, Cahir SZR3014, SZR3018
Co. tipperary, Ireland. SZR3023, SZR3028
SZR3032, SZR3038
FSC Ireland SZR3514, SZR3518
Valid till 03.10.2022. SZR3523, SZR3528
SZR3532, SZR3538
Fee Submitted SZR4014, SZR4018
Rs.50,000/- SZR4023, SZR4028
SZR4032, SZR4038

Class D
Shelf Life : 03 years

72. -do- Legal manufacturer DESyne NECSS Novolimus Approved.

91
 M/s. Elixir Medical Novolimus Drug Drug Eluting
Evaluator: Corporation, 920N.McC Eluting Stent System Stent System
Muhammad Arthy Blvd., Suite 100
Ayub Naveed Milpitas CA 95035 USA. SER2514, SER2518
SER2523, SER2528
Authorized SER2532, SER2538
Representative SER2714, SER2718
M/s. Acorn Regulatory SER2723, SER2728
Consultancy Services SER2732, SER2738
Ltd., Knockmorris, Cahir SER3014, SER3018
Co. tipperary, Ireland. SER3023, SER3028
SER3032, SER3038
FSC Ireland SER3514, SER3518
Valid till 26.07.2022 SER3523, SER3528
SER3532, SER3538
Fee Submitted SER4014, SER4018
Rs.50,000/- SER4023, SER4028
SER4032, SER4038

Class D
Shelf Life : 03 years

73. M/s. Alliance Legal Manufacturer: Biosenser Thermodilutio Approved.

Medical, 12-B, M/s. Biosensors Thermodilution n Catheter
1st Floor, Agro International Pte. Ltd. Catheter and kit
Flats, Shadman, (BSI)
Lahore. 36 Jalan Tukang, SIZES AS PER FSC
Singapore 619266. TD1504, TD1604,
ELI-00147 TD1704, TD1755,
Authorized TD2504, TD2604,
Representative: TD2704, TD2755
M/s. Shanghai BIOTRAY TD1504,
International Holding BIOTRAY TD1604,
Corp. GmbH, eiffestrabe BIOTRAY TD1704,
80, 20537 Hamburg, BIOTRAY TD1755,
Germany. BIOTRAY TD2504,
BIOTRAY TD2604,
FSC Germany BIOTRAY TD2704,
Issued on 14th August, BIOTRAY TD2755,
2018 BIOTRAY TD1502,
BIOTRAY TD1602,
Fee Submitted BIOTRAY TD1702,
Rs.50,000/- BIOTRAY TD1603,
BIOTRAY TD1703,
BIOTRAY TD2502,
BIOTRAY TD2602,
BIOTRAY TD2702,
BIOTRAY TD2603,
BIOTRAY TD2703.

Class D
Shelf Life : 03 years
92
74. -do- Legal Manufacturer: Biosenser Bipolar Bipolar pacing Approved.
M/s. Biosensors Pacing Catheter catheter is
Evaluator: International Pte. Ltd. Sizes: made of
Muhammad (BSI) BP2502-10, BPX2502-10, radiopaque
Ayub Naveed 36 Jalan Tukang, BP2502CS-10, polyurethane
Singapore 619266. BPX2502CS-10. tubing
material that
Authorized Class D allows the use
Representative: Shelf Life : 03 years of fluoroscopy
M/s. Shanghai for guiding the
International Holding Fee Submitted catheter
Corp. GmbH, eiffestrabe Rs.50,000/- during
80, 20537 Hamburg, catheter
Germany. insertion or to
verify its
FSC Germany position when
Issued on 22nd July, 2018 necessary.

75. -do- Legal Manufacturer: OSYPKA TME (Heart OSYPKA Approved.

M/s. OSYPKA AG, Earl- Wire) Temporary
Evaluator: H, Wood-Strasse 1, 79618 (Temporary Myocardial Myocardial
Muhammad Rheinfelden, Germany. Electrode) Electrodes
Ayub Naveed (TMEs)
FSC Germany SIZES / CODES AS
Issued on February 4, PER FSC:
2019
45001, 45002, 45016-01,
Fee Submitted 45017-01, 45023-02,
Rs.50,000/- 45053, 45112, 45200,
45200-G, 45200WS,
45201, 45201WS, 45202,
45202WS, 45001N,
45002N, 45016-01N,
45017-01N, 45023-02N,
45053N, 45112N,
45200N, 45200-GN,
45200WSN, 45201N,
45201WSN, 45202N,
45202WSN, 45009-02,
45009C02, 45011,
45011WS, 45028,
45028BLWS-C, 45028-C,
45041-02, 45041WS02,
45042-02, 45042C02,
45042WS02,
45042WSC02, 45043,
45044-01, 45044C01-PE,
45044WS01,
45044WSC01-PE, 45045,
45045-V, 45045WS,
93
 45055, 45056, 45056-PE,
45057, 45066-PE, 45072-
SL, 45111, 45113, 45205,
45205WS, 45206,
45206WS, 45207,
45207WS, 45209, 46013-
02, 46013C02,
46013WSC02, 46014-02,
46016-01, 46017-02,
46031, 46033-01,
46033C01, 46033WS01,
S5676-01, S5676C01,
45009-02N, 45009C02N,
45011N, 45011WSN,
45028N, 45028BLWS-
CN, 45028-CN, 45041-
02N, 45041WS02N,
45042-02N, 45042C02N,
45042WS02N,
45042WSC02N, 45043N,
45044-01N, 45044C01-
PEN, 45044WS01N,
45044WSC01-PEN,
45045N, 45045-VN,
45045WSN, 45055N,
45056N, 45056-PEN,
45057N, 45066-PEN,
45072-SLN, 45111N,
45113N, 45205N,
45205WSN, 45206N,
45206WSN, 45207N,
45207WSN, 45209N,
46013-02N, 46013C02N,
46013WSC02N, 46014-
02N, 46016-01N, 46017-
02N, 46031N, 46033-
01N, 46033C01N,
46033WS01N, S5676-
01N, S5676C01N.

Class D
Shelf Life : 03 years

76. -do- Legal Manufacturer: CERABLATE Cool Cardiac Approved.

M/s. OSYPKA AG, Earl- Cardiac Ablation Ablation
Evaluator: H, Wood-Strasse 1, 79618 Catheter Catheter.
Muhammad Rheinfelden, Germany.
Ayub Naveed SIZES / CODES AS
FSC Germany PER FSC:
Issued on February 4, 283120, 283121, 283122,
2019 283123, 283124, 283125,
283126, 283127, 283128,
94
 Fee Submitted 283129, 283130, 283131,
Rs.50,000/- 283132, 283133, 283134,
283135, 283136, 283137.

Class D
Shelf Life : 03 years

77. -do- Legal Manufacturer: FINDER/Pure diagnostic Approved.

M/s. OSYPKA AG, Earl- Intracardiac Diagnostic catheters are
Evaluator: H, Wood-Strasse 1, 79618 Catheter. intended for
Muhammad Rheinfelden, Germany. temporary
Ayub Naveed SIZES / CODES AS intracardiac
FSC Germany PER FSC: ECG
Issued on February 4, recording and
2019 24481, 24485, 24489, stimulation of
24415, 24420, 24424, the heart in
Fee Submitted 24482, 24486, 24490, connection
Rs.50,000/- 24416, 24421, 24425, with an
24483, 24487, 24491, external
24484, 24488, 24492, stimulator
24418, 24423, 24427, within the
24470, 24446, 24477, scope of
24401, 24406, 24410, electrophysiol
24471, 24474, 24478, ogical
24472, 24475, 24479, examinations.
24473, 24476, 24480,
24404, 24409, 24403,
24493, 24499, 24429,
24434, 24438, 24444,
24494, 24500, 24430,
24435, 24439, 24495,
24498, 24501, 24496,
24502, 24432, 24437,
24441, 24443, 24510,
24511, 24512, 24513,
24514, 24515, 24516,
24517, 24520, 24521,
24522, 24523, 24524,
24525, 24526, 24527.

Class D
Shelf Life : 03 years

78. -do- Legal Manufacturer: VACS Percutaneous Percutaneous Approved.

M/s. OSYPKA AG, Earl- Transluminal Transluminal
Evaluator: H, Wood-Strasse 1, 79618 Valvuloplasty Balloon Valvuloplasty
Muhammad Rheinfelden, Germany. Catheter. Balloon
Ayub Naveed SIZES / CODES AS Catheter.
FSC Germany PER FSC:
Issued on February 4,
2019 YA0010, YA0011,
95
 YA0012 YA0013,
Fee Submitted YA0014, YA0015
Rs.50,000/- YA0016, YA0018,
YA0019 YA0020,
YA0021, YA0022
YA0023, YA0024,
YA0025 YA0026,
YA0027, YA0028
YA0029, YA0030,
YA0035 YA0036,
YA0037, YA0038
YA0043, YA0044,
YA0045 YA0046,
YA0047, YA0048
YA0049, YA0050,
YA0051 YA0052,
YA0053, YA0054
YA0055, YA0056,
YA0059 YA0060,
YA0061, YA0062
YA0063, YA0064,
YA0065 YA0066,
YA0067, YA0068
YA0069, YA30520,
YA30620 YA30720,
YA30820, YA30830
YA31020, YA31030,
YA31040 YA31220,
YA31230, YA31240
YA31260, YA31430,
YA31440 YA31630,
YA31640, YA31660
YA31830, YA31840,
YA31860 YA32040,
YA32060, YA32240
YA32260, YA32340,
YA32440 YA32460,
YA32540, YA32640
YA32660, YA32840,
YA32860 YA33040,
YA33060

Class D
Shelf Life : 03 years

79. -do- Legal Manufacturer: CERABLATE Easy/TC Cardiac Approved.

M/s. OSYPKA AG, Earl- Cardiac Ablation Ablation
Evaluator: H, Wood-Strasse 1, 79618 Catheter. Catheter.
Muhammad Rheinfelden, Germany.
Ayub Naveed SIZES / CODES AS
FSC Germany PER FSC:
96
 Issued on February 4,
2019 283080, 283081, 283082,
283083, 283084, 283085,
Fee Submitted 283086, 283087, 283088,
Rs.50,000/- 283089, 283090, 283091,
283092, 283093, 283094,
283095, 283096, 283097.

Class D
Shelf Life : 03 years

80. -do- Legal Manufacturer: SELDICATH Arterial Approved.

M/s. Prodimed SAS, (Arterial Catheter) catheter
Evaluator: 6 Rue Louis Armand -
Muhammad 95130 Le, Plessis SIZES / CODES AS
Ayub Naveed Bouchard, France. PER FSC:

FSC France 3842.09, 3843.09,

Issued on 9th October, 3843.12,
2018 3844.09, 3844.12,
Fee Submitted 3846.09,
Rs.50,000/- 3846.12, 3848.12,
3849.12,
3871.07, 3871.10,
3872.07,
3872.10, 3872.13,
3873.10,
3873.13, 3874.10,
3874.13,
3874.17, 3874С10,
3876.10
3876.13, 3876.17,
3876.20,
3881.10, 3881.13,
3881.13L,
3882.10, 3822.13,
3882.17,
3882.20, 3883.10,
3883.13,
3883.17, 3883.20.

Class D
Shelf Life : 05 years

M/s Briogene Manufacturer: Artus® CT/NG QS- In vitro nucleic Approved.

81. Private Limited., M/s Qiagen GmbH RGQ Kit (96) acid
196-A, Sindhi Qiafen Str. 1, 40724 amplification
Muslim, Hilden, Germany Class C test for the
Cooperative quantitation of
Housing Society, (FSC Germany Issuance Shelf Life: 17 Months CMV DNA in
Shahrah-e-Faisal, Date 21-02-2018) human plasma
97
 Karachi Model: 4569365

(ELI-00015)
Fee Submitted
Evaluator: Rs.50,000/-
Muhammad
Ayub Naveed
82. -do- Manufacturer: Artus HSV-1/2 RG The artus Approved.
M/s Qiagen GmbH PCR Kit (24), V1 HSV-1/2 RG
Evaluator: Qiafen Str. 1, 40724 Artus HSV-1/2 RG PCR Kit is a
Muhammad Hilden, Germany PCR Kit (96), V1 real-time
Ayub Naveed based
(FSC Germany Issuance Class C polymerase
Date 21-02-2018) chain reaction
Shelf Life: 24 Months (PCR) assay
for the
Fee Submitted 4500263, 4500265 detection and
Rs.50,000/- discrimination
of human
herpes simplex
virus 1 and 2
DNA

83. -do- Manufacturer: Artus BK Virus RG The Artus BK Approved.

M/s Qiagen GmbH PCR Kit (24), V1 Virus PCR Kit
Evaluator: Qiafen Str. 1, 40724 Artus BK Virus RG is an in vitro
Muhammad Hilden, Germany PCR Kit (96), V1 nucleic acid
Ayub Naveed amplification
(FSC Germany Issuance Class C test for the
Date 21-02-2018) quantitation of
Shelf Life: 24 Months BK virus DNA
Fee Submitted in human
Rs.50,000/- 4514263, 4514265 Plasma or
urine
84. -do- Manufacturer: QFT-Plus tubes Evacuated Approved.
M/s Qiagen GmbH (50xTB1/TB2/Nil/Mito blood
Evaluator: Qiafen Str. 1, 40724 gen) collection tube
Muhammad Hilden, Germany IVD, lithium
Ayub Naveed Class B heparin/gel
(FSC Germany Issuance separator
Date 21-02-2018) Shelf Life: 15 Months QuantiFERON
® -TB Gold
Fee Submitted 622526 Plus (QFT-
Rs.25000/- Plus) Blood
Collection
Tubes

85. -do- Manufacturer: Artus HCV QS RGQ IVD for Approved

M/s Qiagen GmbH Kit, V1 Molecular subject to
Evaluator: Qiafen Str. 1, 40724 Detection kit verification
Muhammad Hilden, Germany 24 Test / Kit for viral load of Fee
Ayub Naveed 72 Test / Kit monitoring of Challan.
98
 (FSC Germany Issuance Hepatitis C
Date 21-02-2018) Class D
Shelf Life: 10 Months
Fee Submitted
Rs.50,000/- 4518363, 4518366,

86. -do- Manufacturer: QuantilFERON® TB IVD Kit for Approved.

M/s Qiagen GmbH Glod Plus stimulation of
Evaluator: Qiagen Str. 1, 40724 Code 622120 effector T cells
Muhammad Hilden, Germany Class C in whole blood
Ayub Naveed with a specific
(FSC Germany Issuance Shelf Life: 36 Months antigen(s) or
Date 21-02-2018). mitogen, and
the subsequent
Fee Submitted simple
Rs.50,000/- quantification
of the resulting
interferon-
gamma in the
plasma
87. -do- Manufacturer: Artus® HI Virus-1 RG An in vitro Approved.
M/s Qiagen GmbH, RT-PCR Kit nucleic acid
Qiagen Str. 1, 40724 1. Artus® HI Virus-1 amplification
Evaluator: Hilden, Germany RG RT-PCR Kit (24), V1 test for the
Unum Zia Code: 4513263 quantitation of
Shamsi (FSC Germany Issue 2. Artus® HI Virus-1 HIV type 1
Date 21-02-2018) RG RT-PCR Kit (96), V1 RNA in
Fee Submitted Code: 4513265 human plasma
Rs.50,000/- Class C
Shelf Life: 20 Months

88. -do- Manufacturer: Artus® HCV QS-RGQ An in vitro Approved.

M/s Qiagen GmbH, Kit (V2) nucleic acid
Evaluator: Qiagen Str. 1, 40724 amplification
Unum Zia Hilden, Germany 1. Artus HCV QS-RGQ test for the
Shamsi Kit (72), V2 quantitation of
(FSC Germany Issue Code: 4538366 hepatitis C
Date 14-12-2018) virus (HCV)
Class C RNA in
Fee submitted Rs human EDTA
50,000/- Shelf Life: 12 Months plasma.

89. -do- Manufacturer: Artus® M.tuberculosis An in Vitro Approved.

M/s Qiagen GmbH, RG PCR Kit nucleic acid
Evaluator: Qiagen Str. 1, 40724 amplification
Unum Zia Hilden, Germany 1. Artus® test for the
Shamsi M.tuberculosis RG PCR detection of all
(FSC Germany Issue Kit (24), V1 members of
Date 21-02-2018) Code: 4555263 the
2. Artus M.tuberculosis M.tubercluosis
99
 RG PCR Kit (96), V1 complex
Code: 4555265 (M.tubercluosi
s,
Class C M.africanum,
M. hovis, M.
Shelf Life: 12 Months bovis BCG, M.
microti, M.
Fee submitted Rs pinnipedii) in
50,000/- human
sputum, BAL,
bronchial
secretion, CSF,
stomach fluid
or peritoneal
punction
samples.

90. M/s Intra Manufacturer: Ligating Clip (Maxi Titanium Approved.

Health, 56A, M/s Qingdao DMD Clip) Ligation Clip
Unit No.1, Medical Technology Co.
Justice Inamullah Ltd., No. 873, Hetao Class C
Road, Block 7/8, Subdistrict Office,
KCHS, Karachi Hongdao Economic Shelf Life: 3 Years
Zone, Qingdao,
(ELI-00049) Shandong, China PLTX220, PLTX230,
PLTX240, PLTX250.
Evaluator: (FSC China Valid Till
Muhammad 01-10-2020)
Ayub Naveed FSC Germany Issue Date
19-10-2018)
Fee Submitted
Rs.50,000/-

91. -do- Manufacturer: MAXi-CLiP® Titanium Approved.

M/s Qingdao DMD Ligating Clip
Evaluator: Medical Technology Co. Class C
Unum Zia Ltd., No. 873, Hetao
Shamsi Subdistrict Office, Shelf Life: 3 Years
Hongdao Economic
Zone, Qingdao, Models:
Shandong, China TCLT100, TCLT200,
TCLT300, TCLT400;
(FSC China Valid Till TCTL5200, TCTL1200,
01-10-2020) TCTL1201, TCTL1202,
TCTL2200, TCTL3200,
(FSC Germany Issue TCTL4200, TCTL100-24,
Date 19-10-2018) TCTL200-24,
Fee Submitted Rs. TCTL1201-24,
50,000/- TCTL2200-24

100
92. M/s. Healthline Legal Manufacturer Belzer UW Cold Belzer UW Approved
Pharmaceutical M/s. Preservation Storage Solution 1000 Cold Storage subject to
Pvt Ltd.Office Solutions, ml. Solution in provision of
No.402, Al- 1099 Proctor Drive, intended for ISO 13485
Hafeez Heights, Elkhorn Wisconsin WI Codes not mentioned the flushing of and Embassy
Gulberg-3, 53121 USA. kidney, liver attested FSC.
Lahore. Class D and pancreas
Name of Disributor: Shelf Life: 24 months. organs at the
(ELI-00 M/s Bridge To Life Ltd., time of
128 Suber Rd, Suite A, removal from
Evaluator: Colimbia, SC USA 29210. the donar in
Muhammad prepartion for
Ayub Naveed FSC USFDA sotrge,
Valid till February 28, transportation
2021 and eventual
transplantatio
Fee Submitted Rs. n into a
50,000/- recipient.
93. M/s Pharma Legal Manufacturer: Sorin Annuloplasty Annuloplasty Approved
Consultant M/s Sorin Group Italia Devices Sovering Mitral Ring subject to
Pakistan (Pvt) S.r.l., Via Crescentino sn, Ring, provision of
Ltd., Suit No.207, 13040 Saluggia (VC) Italy credential of
207 A Khan Class D manufacturer
Tower, DHA (FSC Italy Issuance Date , GMP
Square Walton 02-03-2018) Shelf Life: 5 Years inspection
Road, Lahore report and
Fee Submitted Rs. ICV0839/SA26M, stability
(ELI-00176) 50,000/- ICV0840/SA28M, studies.
ICV0841/SA30M
Evaluator:
Muhammad
Ayub Naveed
94. -do- Legal Manufacturer: Perceval S Biological Biological Approved
M/s Sorin Group Italia Heart Valve (Bovine) Heart Valve subject to
S.r.l., Via Crescentino sn, (Bovine) provision of
13040 Saluggia (VC) Italy Class D credential of
manufacturer
(FSC Italy Issuance Date Shelf Life: 4 Years , GMP
(02-03-2018) inspection
Fee Submitted Rs. ICV1208/PVS21, report and
50,000/- ICV1209/PVS23, stability
ICV1210/PVS25, studies.
ICV1211/PVS27
95. -do- Legal Manufacturer: Carbomedics Carbo- Aortovalvular Approved
M/s Sorin Group Italia Seal (Aortovalvular Prostheses subject to
S.r.l., Via Crescentino sn, Prostheses) provision of
13040 Saluggia (VC) Italy credential of
Manufacturer: Class D manufacturer
M/s LivaNova Canada , GMP
Corp., 5005 North Fraser Shelf Life: 4 Years inspection
Way, Burnaby, British report and
Colombia, V5J 5M1 AP-021, AP-023,AP-025, stability
101
 Canada AP-027, AP-029, studies.
(FSC Italy Issuance Date AP-031, AP-033
(02-03-2018)

Fee Submitted Rs.

50,000/-
96. -do- Legal Manufacturer: Carbomedics Annuloflo Annuloplasty Approved
M/s Sorin Group Italia Devices for Ring subject to
S.r.l., Via Crescentino sn, Annuloplasty provision of
13040 Saluggia (VC) Italy credential of
(FSC Italy Issuance Date Class D manufacturer
02-03-2018) Shelf Life: 5 Years , GMP
AR-726, AR-728, AR- inspection
Fee Submitted Rs. 730, report and
50,000/- AR-732, AR-734, AR- stability
736, studies.

-do- Legal Manufacturer: Solo Smart Biological Stent-less Approved

M/s Sorin Group Italia Heart Valve Biological subject to
S.r.l., Via Crescentino sn, Class D Heart Valve provision of
13040 Saluggia (VC) Italy Shelf Life: 4 Years credential of
ICV1246/ART19SMT, manufacturer
(FSC Italy Issuance Date ICV1247/ART21SMT, , GMP
02-03-2018) ICV1248/ART23SMT, inspection
ICV1264/ART25SMT, report and
Fee Submitted Rs. ICV1265/ART27SMT stability
50,000/- studies.

97. -do- Legal Manufacturer: Pericarbon More-mod Biological Approved

M/s Sorin Group Italia Mitral Heart Valve subject to
S.r.l., Via Crescentino sn, Class D provision of
13040 Saluggia (VC) Italy Shelf Life: 4 Years credential of
(FSC Italy Issuance Date ICV0766/PS19, manufacturer
02-03-2018) ICV0767/PS21, , GMP
ICV0768/PS23, inspection
Fee Submitted Rs. ICV0769/PS25, report and
50,000/- ICV0770/PS27, stability
ICV0771/PS29, studies.
ICV0772/PS31,
ICV0773/PS33

98. -do- Legal Manufacturer: Devices for Annuloplasty Approved

M/s Sorin Group Italia Annuloplasty Memo Ring subject to
S.r.l., Via Crescentino sn, 3D, provision of
13040 Saluggia (VC) Italy Class D credential of
Shelf Life: 5 Years manufacturer
(FSC Italy Issuance Date , GMP
(02-03-2018) ICV0966/SMD24, inspection
ICV0967/SMD26, report and
Fee Submitted Rs. ICV0968/SMD28, stability
50,000/- ICV0969/SMD30, studies.
102
 ICV0970/SMD32,
ICV0971/SMD32,
ICV0972/SMD36,
ICV0973/SMD38

99. -do- Manufacturer: Carbomedics Heart Mechanical Approved

M/s Sorin Group Italia Valve (Mitral) Heart Valve subject to
S.r.l., Via Crescentino sn, provision of
13040 Saluggia (VC) Italy Class D credential of
manufacturer
(FSC Italy Issuance Date Shelf Life: 5 Years , GMP
02-03-2018) inspection
Carbomedics Standard report and
Fee Submitted Rs. Mitral stability
50,000/- M7-016, M7-018, M7- studies.
021,
M7-023, M7-025, M7-
027,
M7-029, M7-031, M7-
033

Carbomedics Orbis
Mitral
M2-021, M2-023, M2-
025,
M2-027, M2-029, M2-
031,
M2-033

Carbomedics Optiform
Mitral
F7-021, F7-023, F7-025,
F7-027, F7-029, F7-031,
F7-033

100. -do- Manufacturer: Carbomedics Heart Mechanical Approved

M/s Sorin Group Italia Valve (Aortic) Heart Valve subject to
S.r.l., Via Crescentino sn, provision of
13040 Saluggia (VC) Italy Class D credential of
manufacturer
(FSC Italy Issuance Date Shelf Life: 5 Years , GMP
02-03-2018) inspection
Carbomedics Standard report and
Fee submitted Rs. Aortic stability
50,000/- A5-016, A5-018, A5-019, studies.
A5-021, A5-023, A5-025,
A5-027, A5-029, A5-031

Carbomedics Reduced
Aortic
R5-019, R5-021, R5-023,
R5-025, R5-027, R5-029
103
 Carbomedics Supra-
Annular Aortic (Top
Hat)
S5-019, S5-021, S5-023,
S5-025, S5-027

Carbomedics Orbis
Aortic
A1-019, A1-021, A1-023,
A1-025 A1-027, A1-029,
A1-031

101. -do- Manufacturer: Crown PRT Aortic Approved

M/s LivaNova Canada Pericardial subject to
Corp., 5005 North Fraser Class D Heart Valve provision of
Way Burnaby, British credential of
Columbia V5J 5M1, Shelf Life: 5 Years manufacturer
Canada , GMP
CNA19, CNA21, inspection
(FSC Canada Issuance CNA23, CNA25, report and
Date 05-07-2018) CNA27, CNA29 stability
studies.
Fee submitted Rs.
50,000/-

102. -do- Manufacturer: Carbomedics Standard Prosthetic Approved.

M/s Sorin Group Italia Mitral Heart Valve
Evaluator: S.r.l., Via Crescentino sn,
Unum Zia 13040 Saluggia (VC) Italy Class D
Shamsi
(FSC Italy Issue Date Shelf Life: 5 Years
02-03-2018)
Fee submitted: Rs M7-016, M7-018, M7-
50,000/- 021,
M7-023, M7-025, M7-
027,
M7-029, M7-031, M7-
033

103. -do- Manufacturer: Carbomedics Standard Prosthetic Approved.

M/s Sorin Group Italia Aortic Heart Valve
Evaluator: S.r.l., Via Crescentino sn,
Unum Zia 13040 Saluggia (VC) Italy Class D
Shamsi
(FSC Italy Issue Date Shelf Life: 5 Years
02-03-2018)
Fee submitted: Rs Codes: A5-016, A5-018,
50,000/- A5-019, A5-021, A5-023,
A5-025, A5-027, A5-029,
A5-031

104
104. -do- Manufacturer: Crown PRT Aortic Approved.
M/s LivaNova Canada Pericardial
Evaluator: Corp., 5005 North Fraser Class D Heart Valve
Unum Zia Way Burnaby, British
Shamsi Columbia V5J 5M1, Shelf Life: 5 Years
Canada
CNA19, CNA21,
(FSC Canada Issue Date CNA23, CNA25,
05-07-2018) CNA27, CNA29
Fee submitted:
Rs.50,000/-

105. M/s The Searle Manufactured By: Medco® Inject Single Sterile Approved
Company M/s Abu Dhabi Medical Use Syringe 10ml Hypodermic subject to
Limited, 1st Devices Co, L.L.C Syringes foreign
Floor, NICL Mussafah City M43 – Class B inspection of
Building, Abbasi Block 124, P O Box the
Shaheed Road, 30485, Abu Dhabi, UAE Shelf Life: 3 Years manufacturer
Karachi abroad. The
(FSC UAE Valid Till Board also
(ELI-00057) 23-01-2019) authorized
the Secretary,
Evaluator: Fee. submitted Rs. MDB to issue
Muhammad 25000/- registration
Ayub Naveed letter if the
manufacturin
g plant is
aqpproved
by the expert
panel.

106. -do- Manufacturer/Manufact Medeco® Inject Re-use Re-Use Approved

uring site: Prevention Syringe Prevention subject to
Evaluator: M/s Abu Dhabi Medical Syringes foreign
Unum Zia Devices Co, L.L.C Class B inspection of
Shamsi Mussafah City M43 –Plot the
124, P O Box 30485, Abu Shelf Life: 3 Years manufacturer
Dhabi, UAE abroad. The
2/3 ml and 5 ml Board also
(FSC UAE Valid Till authorized
27-12-2020) the Secretary,
Fee submitted MDB to issue
Rs.25000/- registration
letter if the
manufacturin
g plant is
aqpproved
by the expert
panel.

107. M/s. 4A Manufacturer Detro FORTE Instrument Approved.

InternationalPlot M/s. Detro Healthcare (Gluteraldeyude 2%) and
105
 7, street No Kimya Sanayi A.S. Endoscope
11,lawyers Ataturk mh. Adnan Detro Forte 5 L Disinfectant
Society, Menderes cd. No: 7
Chaklala, Esemyurt / Istanbul, Class C
Rawalpindi. Turkey.
Shelflife : 02 years
Evaluator: FSC Spain
Hafiz Issued on 14th Nov, 2018
Muhammad Asif
Iqbal Fee submitted
Rs.50,000/-

108. M/s. A.K Legal Manufacturer: Silhouette Soft Silhouette Soft Approved.
Pharma (Pvt) M/s. Silhouette Lift Inc., is intended to
Ltd., Zone 2557, I Technology Drive Suite SMS22 be used for
2nd Floor, F211 Irvine, California SMS23 facial
Adjucent Total 92618 USA. SMS25 reconstruction
Parco, Firdos SMS100 in the
Market, Lahore. Manufacturing Site: SMS102 treatemnt, for
M/s. Vaupell Corporate instance, of
ELI-00360 Office, 1144-N, W 53rd Class D facial
Seattle, WA 98107 USA. Shelf Life : 18 months lipoatrophy or
Evaluator: morphological
Muhammad FSC U.K asymmetry.
Ayub Naveed Issued on 11.04.2018
109. -do- Legal Manufacturer: Aqtis Medical Dermal ELLANSE TM is Approved.
M/s. AQTIS Medical BV Filler a sterile, latex-
Evaluator: Yalelaan 44,3584 CM free, non-
Muhammad Utrecht, the Netherlands. EllanseTM S pyrogenci,
Ayub Naveed EllanseTM M totally bio
FSC Netherlands EllanseTM L resorable, non-
Valid till 0108.2022 EllanseTM E permanent
implant,
Class D whose
Shelf Life : 02 years principle
component is
synthetic Poly-
e-Caprolacton
(PCL)
microsphers
suspended ina
gel carrier of
phosphate
buffered saline
(Ph.Eur),
glycerin
(Ph.Eur) and
carboxymethyl
celluose (USP).
110. -do- Legal Manufacturer: Perfectha Perfectha is a Approved.
M/s. Obvieline SAS, (Cross linked injectable line of re
Evaluator: 8 Chemin du Jubin, F- Hyaluronic acid) asorbable
106
 Muhammad 69570, France hyaluronic cid
Ayub Naveed Perfectha(R) Finelines (HA) gel
FSC France (FDFL) implants
Issued on 17.01.2018 Perfectha(R) intended for
Complement(PDC) reconstructive
Perfectha(R) Derm (PD) purposes in
Perfectha(R) Deep the treatment,
(PDD) for
Perfectha(R) Subskin instance, of
(PDSS3) facial
Perfectha(R) Subskin lipoatrophy, or
(PDSS1) morphological
asymmetry
associated
with the aging
process or
other
underlying
conditions.
Perfectha is for
intradermal
and
subcutaneous
application
and is
implanted in
the areas of the
face and hands
to fill skin
depressions
and Iso for the
augmentation
of tissue
volume.
111. M/s. TEK Legal Manufacturer : ASAHI Peripheral This Approved.
Enterprises, M/s. ASAHI Intecc co., Guide Wire Peripheral
Office No. MZ-9, ltd.,3-100 Akatsuki-cho, (Peripheral Guide guide wire
al-Hafeez Seto, Aichi 489-0071 Wire) has a coil-type
Heights Sir Syed Japan. distal end or a
Road, Gulberg,  ASAHI Peripheral plastic
Lahore. Manufacturing Sites: Guide Wire ASAHI covered-type
Gladius distal end.
ELI-00189 1) ASAHI INTECC  ASAHI Peripheral The coil is
CO., LTD. Guide Wire ASAHI partly or
3-100 Akatsuki-cho, Halberd entirely
489-0071 Seto, Aichi,  ASAHI Peripheral radiopaque to
Japan. Guide Wire ASAHI facilitate
Gaia PV selection of
2) ASAHI INTECC  ASAHI Peripheral the blood
(Thailand) CO., LTD. Guide Wire ASAHI vessel and
158/1 Moo 5 Astato XS 40 confirmation
Bangkadi Industrial of the position
107
 Park,  ASAHI Peripheral of the guide
Tiwanon Road, Guide Wire Astato wire’s distal
Tambol Bangkadi, XS 20 end by
Amphur Muang,  ASAHI Peripheral fluoroscopy.
Pathumthani 12000, Guide Wire Astato The core shaft
Thailand. 30 surface is
 ASAHI Peripheral coated with
3) ASAHI INTECC Guide Wire Regalia Polytetrafluor
HANOI CO., LTD. XS 1.0 oethylene
THANG LONG  ASAHI Peripheral (PTFE). About
Industrial Park,Dong Guide Wire 2cm of the
Anh District, Hanoi, Treasure 12 distal end can
Vietnam  ASAHI Peripheral be shaped.
Guide Wire
FSC Japan Treasure Floppy Intended Use:
Issued on 25th July, 2018 This Product is
Class C intended to
facilitate the
Shelf Life : 03 years
placement and
exchange of
diagnostic and
therapeutic
devices during
intravascular
procedures.
This device is
intended for
peripheral
vascular use
only.
112. -do- Legal Manufacturer : Asahi Sasuke Double Intended use: Approved.
M/s. ASAHI Intecc co., Lumen Catheter This product is
Evaluator: ltd.,3-100 Akatsuki-cho, (RX/OTW) intended to be
Muhammad Seto, Aichi 489-0071 (Double Lumen used in
Ayub Naveed Japan. Catheter) conjunction
with steerable
Manufacturing Sites: Flush needle is guidewires in
included in the package order to access
1) ASAHI INTECC of ASAHI SASUKE discrete
regions of the
(Thailand) CO., LTD. with thedevice.
coronary
158/1 Moo 5
arterial
Bangkadi Industrial Class D vasculature.
Park, Shelf Life : 03 years
Tiwanon Road,
Tambol Bangkadi,
Amphur Muang,
Pathumthani 12000,
Thailand.

FSC Japan
Issued on 18th October,
2018

108
113. -do- Legal Manufacturer : ASAHI Corsair Pro Intended use: Approved.
M/s. ASAHI Intecc co., (Microcatheter) The ASAHI
Evaluator: ltd.,3-100 Akatsuki-cho, Corsair Pro is
Muhammad Seto, Aichi 489-0071 Class D intended to
Ayub Naveed Japan. Shelf Life : 03 years provide
support to
Manufacturing Sites: facilitate the
placement of
ASAHI INTECC guide wires in
the coronary
(Thailand) CO., LTD.,
and peripheral
158/1 Moo 5 Bangkadi
vasculature,
Industrial Park, and can be
Tiwanon Road, Tambol used to
Bangkadi, Amphur exchange one
Muang, guide wire for
Pathumthani 12000, another. The
Thailand. ASAHI
Corsair Pro is
FSC Japan also intended
Issued on 25th July , 2018 to assist in the
delivery of
contrast media
into the
coronary,
peripheral and
abdominal
vasculature.
this device is
not intended
for use in
neurovasculat
ure.
114. M/s Global Legal Manufacturer: SMART® ControlTM Nitinol Stent Approved.
Marketing M/s Cordis Cashel Cahir Nitinol Stent System System is
Services, 111, Road Cashel Co. Designed to
Hali Road Tipperary , Ireland Class C deliver a self
Westridge 1, Manufacturing Site: expanding
Rawalpindi M/s Cordis de Mexico Shelf Life: 2 Years stent to the
S.A. de C.V, Calle peripheral
(ELI-000109) Circuito Interior Norte # Codes & sizes as per vasculature via
1820, Parque Industrial FSC OF Ireland a sheathed
Evaluator: Salvarcar, Ciudad Juarez, delivery
Muhammad Chihuahua, CP32574, system
Ayub Naveed Mexico

(FSC Ireland Valid Till

11-04-2023)

Fee Rs. 50000/-

115. -do- Legal Manufacturer: High Flow Diagnostic Coronary Approved.

109
 M/s Cordis Corporation, Catheter Angiographic
Evaluator: 14201 N.W. 60th Ave. Diagnostic
Muhammad Miami Lakes, FL 33014, Class D Catheters
Ayub Naveed USA
Shelf Life: 3 Years

Manufacturing Site: 527710 Cath. Judkins

M/s Cordis de Mexico L4.5 7HF 100cm
S.A. de C.V, Calle
Circuito Interior Norte #
1820, Parque Industrial
Salvarcar, Ciudad Juarez,
Chihuahua, CP32574,
Mexico

(FSC USFDA Valid Till

13-08-2019)

Fee Rs. 50000/-

116. -do- Legal Manufacturer: MAXI LD PTA Balloon PTA Balloon Approved.
M/s Cordis Cashel Cahir Dialtation Catheter Dialtation
Evaluator: Road Cashel Co. Catheter
Muhammad Tipperary , Ireland Class D
Ayub Naveed
Manufacturing Site: Shelf Life: 1.5 Years
M/s Cordis de Mexico
S.A. de C.V, Calle Codes & sizes as per
Circuito Interior Norte # FSC
1820, Parque Industrial
Salvarcar, Ciudad Juarez,
Chihuahua, CP32574,
Mexico

(FSC Ireland Valid Till

09-01-2023)

Fee submitted
Rs.50,000/-

117. -do- Legal Manufacturer: ADROIT Guiding Guiding Approved.

M/s Cordis Corporation Catheters Catheters
Evaluator: 14201 N.W. 60th Ave.
Muhammad Miami Lakes, FL 33014 Class D
Ayub Naveed USA
Shelf Life: 3 Years
Manufacturing Site:
M/s Cordis de Mexico Codes & Sizes as per
S.A. de C.V, Calle USDFA FSC
Circuito Interior Norte #
1820, Parque Industrial
Salvarcar, Ciudad Juarez,
Chihuahua, CP32574,
110
 Mexico

(FSC USFDA Valid Till

15-06-2019)

Rs.50,000/-

118. -do- Legal Manufacturer: POWERFLEX® PRO PTA Balloon Approved.

M/s Cordis Corporation PTA Balloon Dilatation Dialtation
Evaluator: 14201 N.W. 60th Ave. Catheter Catheter
Muhammad Miami Lakes, FL 33014
Ayub Naveed USA Class D

Manufacturing Site: Shelf Life: 3 Years

M/s Cordis de Mexico
S.A. de C.V, Calle Codes & Sizes as per
Circuito Interior Norte # FSC
1820, Parque Industrial
Salvarcar, Ciudad Juarez,
Chihuahua, CP32574,
Mexico

Contract Manufacturer:
M/s Nitinol Devices &
Components Costa Rica
S.R.L. Coyol Free Zone,
Building B14, B15, B25 El
Coyol, Alajuela 2 01 02
Costa Rica

(FSC USFDA Valid Till

29-08-2019)

Rs.50,000/-

119. -do- Legal Manufacturer/ VIDAS CMV IGM IVD for Approved.
Manufacturering Site: (Cytomegalovirus automated
Evaluator: M/s. BioMérieux SA (CMV) qualitative
Muhammad 376 chemin de l’Orme immunoglobulin M enzyme
Ayub Naveed 69280 Marcy l’Etoile – (IgM) antibody IVD) immunoassay
France for use on the
VIDAS CMV IGM VIDAS family
instruments,
FSC France Class C for the
Issued on 11thDecember, Shelf Life : 11 months detection of
2017 approx.. anti-
cytomegalovir
Rs. 50,000 us IgM
(CMVM) in
human serum,
using the
ELFA
111
 technique
(Enzyme
Linked
Fluorescent
Assay)

120. -do- Legal Manufacturer VIDAS RUB IGM VIDAS CMV Approved.
and Manufacturing site: (Rubella virus IgG is an
Evaluator: M/s. BioMérieux SA immunoglobulin M automated
Muhammad 376 chemin de l’Orme (IgM) antibody IVD) quantitative
Ayub Naveed. 69280 Marcy l’Etoile – enzyme
France VIDAS CMV IGG immunoassay
for use on the
Class C VIDAS family
FSC France Shelf Life : 11 months instruments
Issued on 11th December, approx.. for the
2017 quantitative
measurement,
Fee submitted Rs. 50,000 of anti-
cytomegalovir
us IgG
(CMVG) in
human serum,
using the
technique
ELFA
(Enzyme
Linked
Fluorescent
Assay).

121. -do- Legal Manufacturer VIDAS RUB IGM IVD for Approved.
and Manufacturing site: (Rubella virus qualitative
Evaluator: M/s. BioMérieux SA immunoglobulin M automated
Muhammad 376 chemin de l’Orme (IgM) antibody IVD) enzyme
Ayub Naveed 69280 Marcy l’Etoile – immunoassay
France VIDAS RBM IGM for use on the
VIDAS family
FSC France Class C instruments,
Issued on 11th December, Shelf Life : 11 months for the
2017 approx.. detection of
anti-rubella
Fee submitted Rs. 50,000 IgM (RBM) in
human serum
using the
ELFA
technique
(Enzyme
Linked
Fluorescent
Assay).

112
122. -do- Legal Manufacturer VIDAS TPSA IVD for Approved.
and Manufacturing site: (Total prostate specific automated
Evaluator: M/s. BioMérieux SA antigen (PSA) IVD) quantitative
Muhammad 376 chemin de l’Orme test for use on
Ayub Naveed 69280 Marcy l’Etoile – VIDAS TPSA the VIDAS
France family
Class C instruments,
FSC France Shelf Life : 12 months for the
Issued on 11th December, approx.. quantitative
2017 measurement
of prostate
Fee submitted Rs. 50,000 specific
antigen (PSA)
levels in
human serum
or plasma
(lithium
heparin or
EDTA), using
the
ELFA
technique
(Enzyme
Linked
Fluorescent
Assay).
123. -do- Legal Manufacturer VIDAS TOXO IGM IVD for Approved.
and Manufacturing site: (Toxoplasma gondii automated
Evaluator: M/s. BioMérieux SA immunoglobulin M qualitative test
Muhammad 376 chemin de l’Orme (IgM) antibody IVD) for use on the
Ayub Naveed 69280 Marcy l’Etoile – VIDAS family
France VIDAS TOXO IGM instruments,
for the
FSC France Class C detection of
Issued on 11th December, Shelf Life : 10 months anti-
2017 toxoplasma
IgM in serum
Fee submitted Rs. 50,000 using the
ELFA
technique
(Enzyme
Linked
Fluorescent
Assay).

124. -do- Legal Manufacturer VIDAS RUB IGG II VIDAS RUB Approved.
and Manufacturing site: (Rubella virus IgG II (RBG) is
Evaluator: M/s. BioMérieux SA immunoglobulin G an automated
Muhammad 376 chemin de l’Orme (IgG) antibody IVD) quantitative
Ayub Naveed 69280 Marcy l’Etoile – test for use on
France VIDAS RUB IGG II the VIDAS
family
113
 FSC France Class C instruments,
Issued on 11th December, Shelf Life : 13 months for the
2017 quantitative
measurement
Fee submitted Rs. 50,000 of
immunoglobul
ins G (IgG)
directed
against the
Rubella virus
in human
serum or
plasma
(heparin or
EDTA) using
the ELFA
technique
(Enzyme
Linked
Fluorescent
Assay).

125. -do- Legal Manufacturer: VIZUMAX HD Vizumax HD Approved.

Vizumax Diagnostics (Barium Sulfate) 98% is a high-
Evaluator: LLC density barium
Muhammad 609 Broadway Avenue, VIZUMAX HD 98% - sulfate that is
Ayub Naveed Orlando, Florida 32803, 340 g (Product #2030- used to help
USA 16) doctors
VIZUMAX HD 98% - 5 examine the
Manufacturing Site: kg (Product #2030-50) esophagus,
Vizumax Diagnostics stomach and
LLC Class B intestines,
2225E Belt Line Rd # 105, using x-rays.
Carrolton, Texas 75006, Shelf Life : 02 years The chemical
USA. formula of
barium sulfate
FSC USFDA is BaSO4. This
Valid until May 3, 2020 product is
indicated for
Fee submitted use as a
Rs.25,000/- contrast agent
in
radiographic
studies.

126. -do- Legal Manufacturer: SUPER Torque® Indicated for Approved.

M/s Cordis Corporation, Angiographic Catheter the
Evaluator: 14201 N.W. 60th Ave. angiographic
Unum Zia Miami Lakes, FL 33014, Class D visualization
Shamsi USA and linear
Shelf Life: 3 Years measurement
Manufacturing Site: of the arterial
114
M/s Cordis de Mexico 6F Super Torque and venous
S.A. de C.V, Calle Angiographic Catheter vasculature for
Circuito Interior Norte #  532618 a wide range
1820, Parque Industrial  532619 of disease
Salvarcar, Ciudad Juarez,  532620 processes such
Chihuahua, CP 32574,  532621 as coronary
Mexico  532622 artery disease,
 532623 peripheral
(FSC USFDA Valid Till vascular
 532624
13-08-2019). disease,
 532625
embolization
Fee submitted: Rs  532627 of anomalous
50,000/-  532628 vessels and
 532640 endovascular
 532642 aortic repair
 532644 (AAA,
 532645 TEVAR).
 532646
 532647
 532648
 532649
 532650S
 532652S
 532654S
 532660
 532661
 532662
 532663
 532664
 532668
 532669
 532670
 532672
 532680N
 532681
 532682
 532683
 532684
 532685
 532685N
 532686
 532695
 532696
 532697
 532698
 532699
 455660
 455660D
 455661

115
  455662
 455663
 455665
 455666
 455671
 455672
 455686
 455689
 455698
Super Torque
Angiographic Catheter
 455610T
 455611T
 455613E
 455623
 455636
 455637
 532410T
 532411T
 532412T
 532413T
 532420T
 532421T
 532422T
 532424
 532425
 532426
 532427
 532430
 532431
 532432
 532457
 532482
 532506
 532507
 532508
 532539F8
 532555H8
 532564V8
 532569H8
4F Super Torque
Angiographic Catheter
 532405
 532414
 532415
 532416
 532417
 532436
 532437
116
  532438
 532461
 532463
 532470
 532433
 532434
 532439
 532440
 532441
 532442
 532443
 532444
 532445
 532447
 532448
 532449
 532462
 532473
 532474
 532478
 532489
 532490
 532491
 532492
 532493
 532494
 532497
5F Super Torque
Angiographic Catheters
 532501
 532502
 532503
 532504
 532505
 532509
 532510
 532511
 532512
 532513
 532514
 532515
 532516
 532517
 532518
 532519
 532520
 532521
 532522

117
  532523
 532524V8
 532533
 532541H0
 532543H0
 532546
 532547
 532548
 532549H0
 532565
 532566
 532567
 532568
 532571
 532576
 532578
 532579
 532586
 532589
 532591
 532592
 532593

127. -do- Legal Manufacturer: SABERTM PTA Balloon Percutaneous Approved.

M/s Cordis Cashel Cahir Dilatation Catheter Transluminal
Evaluator: Road Cashel Co. Angioplasty
Unum Zia Tipperary , Ireland Class D (PTA)
Shamsi Dilatation
Manufacturing Site: Shelf Life: 3 Years Catheter with
Nitinol Devices, S.R.L. a distal
Coyol Free Zone, Codes inflatable
Buildings B14, B15 and  48002002S
B25 El Coyol, Alajuela  48002003S
20102, Costa Rica  48002004S
 48002006S
(FSC Ireland Valid Till  48002008S
06-09-2023)  48002010S
Fee submitted: Rs
 48002015S
50,000/-
 48002020S
 48002025S
 48002030S
 48006002S
 48006003S
 48006004S
 48006006S
 48006008S
 48006010S
 48006015S
118
 48006020S
 48006025S
 48006030S
 48002502S
 48002503S
 48002504S
 48002506S
 48002508S
 48002510S
 48002515S
 48002520S
 48002525S
 48002530S
 48007002S
 48007003S
 48007004S
 48007006S
 48007008S
 48007010S
 48003002S
 48003003S
 48003004S
 48003006S
 48003008S
 48003010S
 48003015S
 48003020S
 48003025S
 48003030S
 48008002S
 48008003S
 48008004S
 48008006S
 48008008S
 48008010S
 48003502S
 48003503S
 48003504S
 48003506S
 48003508S
 48003510S
 48003515S
 48003520S
 48003525S
 48003530S
 48009002S
 48009003S
 48009004S

119
 48009006S
 48009008S
 48009010S
 48004002S
 48004003S
 48004004S
 48004006S
 48004008S
 48004010S
 48004015S
 48004020S
 48004025S
 48004030S
 48010002S
 48010003S
 48010004S
 48010006S
 48010008S
 48010010S
 48005002S
 48005003S
 48005004S
 48005006S
 48005008S
 48005010S
 48005015S
 48005020S
 48005025S
 48005030S
 48002002X
 48002003X
 48002004X
 48002006X
 48002008X
 48002010X
 48002015X
 48002020X
 48002025X
 48002030X
 48006002X
 48006003X
 48006004X
 48006006X
 48006008X
 48006010X
 48006015X
 48006020X
 48006025X

120
 48006030X
 48002502X
 48002503X
 48002504X
 48002506X
 48002508X
 48002510X
 48002515X
 48002520X
 48002525X
 48002530X
 48007002X
 48007003X
 48007004X
 48007006X
 48007008X
 48007010X
 48003002X
 48003003X
 48003004X
 48003006X
 48003008X
 48003010X
 48003015X
 48003020X
 48003025X
 48003030X
 48008002X
 48008003X
 48008004X
 48008006X
 48008008X
 48008010X
 48003502X
 48003503X
 48003504X
 48003506X
 48003508X
 48003510X
 48003515X
 48003520X
 48003525X
 48003530X
 48004002X
 48004003X
 48004004X
 48004006X
 48004008X

121
  48004010X
 48004015X
 48004020X
 48004025X
 48004030X
 48005002X
 48005003X
 48005004X
 48005006X
 48005008X
 48005010X
 48005015X
 48005020X
 48005025X
 48005030X

128. -do- Legal Manufacturer: SHINOBI® Plus Used to aid in Approved.

M/s Cordis Corporation Steerable Guidewire the
Evaluator: 14201 N.W. 60th Ave. introduction
Unum Zia Miami Lakes, FL 33014 1. 547214 SGW and
Shamsi USA SHINOBI PLUS 180cm positioning of
catheters and
Manufacturing Sites: 2. 547214X SGW interventional
(i) M/s Lake Region SHINOBI PLUS 300cm devices within
Medical, 340 Lake the coronary
Hazeltine Dr, Chaska, Class D and peripheral
MN 55318 USA vasculature
Shelf Life : 2 Years
(ii) M/s Lake Region
Medical Limited,
Butlersland,New Ross, Fee submitted: 50,000/-
Wexford, Ireland

(FSC USFDA Valid Till

14-06-2019)

129. -do- Legal Manufacturer: TEMPO® Angiographic Angiographic Approved.

M/s Cordis Corporation, Catheter Catheter
Evaluator: 14201 N.W. 60th Ave.
Unum Zia Miami Lakes, FL 33014, Class D
Shamsi USA
Shelf Life: 3 Years
Manufacturing Site:
M/s Cordis de Mexico TEMPO 4F
S.A. de C.V, Calle  451401F5
Circuito Interior Norte #  451401H5
1820, Parque Industrial  451401L5
Salvarcar, Ciudad Juarez,  451401V5
Chihuahua, CP32574,  451401V5J
Mexico  451402F5

122
(FSC USFDA Valid Till  451402H5
13-08-2019).  451402L5
 451402V5
Fee submitted: Rs  451403F5
50,000/-  451403H5
 451403L5
 451403V5
 451404F5
 451404V5
 451406H0
 451406H2
 451406P0
 451406P2
 451406S0
 451406S2
 451406V0
 451407H2
 451407S2
 451407V0
 451408V2
 451412H0
 451413H0
 451413T0
 451413V0
 451414H0
 451415H0
 451415T0
 451415V0
 451418S0
 451420H0
 451421H0
 451423H0
 451424H0
 451425H0
 451430H0
 451430H0J
 451430H2
 451431H0
 451431H2
 451432H0
 451432H2
 451435H0
 451435H0J
 451439H0
 451439H0J
 451442V0
 451442V2
 451443H0

123
  451443V0
 451443V0J
 451443V2
 451444V0
 451444V2
 451446S0
 451446S2
 451447S0
 451447S2
 451449V0
 451450V0
 451450V0J
 451455V0
 451456V0
 451456V0J
 451457V0

TEMPO 5F
 451501F5
 451501H5
 451501L5
 451501V5
 451502F5
 451502L5
 451502V5
 451503F5
 451503H5
 451503L5
 451503V5
 451504F5
 451504L5
 451504V5
 451506H0
 451506H2
 451506P0
 451506P2
 451506S0
 451506S2
 451506V0
 451507H0
 451507H2
 451507S0
 451507S2
 451507V0
 451508V2
 451512H0
 451513H0
 451513V0

124
  451514H0
 451515H0
 451515T0
 451515V0
 451518S0
 451520H0
 451521H0
 451523H0
 451524H0
 451525H0
 451530H0
 451530H2
 451531F2
 451531H0
 451531H2
 451532H0
 451532H2
 451535H0
 451539H0
 451542V0
 451542V2
 451543H0
 451543V0
 451544V0
 451544V2
 451546S0
 451546S2
 451546V2
 451547S0
 451547S2
 451549V0
 451550V0
 451550VJ
 451555V0
 451556V0
 451557V0
 451591V5
 451593V5

130. -do- Legal Manufacturer: TEMPO® AQUA® Angiographic Approved.

M/s Cordis Corporation, Angiographic Catheter Catheter
Evaluator: 14201 N.W. 60th Ave.
Unum Zia Miami Lakes, FL 33014, Class D
Shamsi USA
Shelf Life: 3 Years
Manufacturing Site:
M/s Cordis de Mexico TEMPO AQUA — 4F
S.A. de C.V, Calle  452407H0
125
 Circuito Interior Norte #  452412H0
1820, Parque Industrial  452413H0
Salvarcar, Ciudad Juarez,  452414H0
Chihuahua, CP32574,  452418S0
Mexico  452421H0
 452423H0
(FSC USFDA Valid Till
 452430H0
13-08-2019)
 452431H0
Fee submitted: Rs
50,000/-  452435H0
 452442V0
 452443S0
 452443V0
 452447S0
 452450V0

TEMPO AQUA — 5F
 452507H0
 452514H0
 452518S0
 452521H0
 452523H0
 452530H0
 452531H0
 452535H0
 452542V0
 452543S0
 452543V0
 452547S0
 452550V0

131. -do- Legal Manufacturer: SMART® Flex Vascular Self expanded Approved.
M/s Cordis Cashel Cahir Stent System Nitinol
Evaluator: Road Cashel Co. Vascular Stent
Unum Zia Tipperary , Ireland Class D System
Shamsi
Manufacturing Site: Shelf Life: 2 Years
M/s Burpee Material
Technology LLC, 15  SF08030MV
Christopher Way,  SF05040MV
Eatontown, New Jersey,  SF06040MV
07724 USA  SF07040MV
 SF05060MV
(FSC Ireland Valid Till  SF06060MV
14-06-2022)
 SF07060MV
 SF08060MV
Fee submitted: Rs
50,000/-  SF05080MV
 SF06080MV
 SF07080MV

126
 SF05100MV
 SF06100MV
 SF07100MV
 SF08100MV
 SF05120MV
 SF06120MV
 SF07120MV
 SF05150MV
 SF06150MV
 SF07150MV
 SF08150MV
 SF05200MV
 SF06200MV
 SF07200MV
 SF08040SV
 SF08080SV
 SF08120SV
 SF08200SV
 SF08040MV
 SF08080MV
 SF08120MV
 SF08200MV
 SF09020SV
 SF10020SV
 SF09030SV
 SF10030SV
 SF09040SV
 SF10040SV
 SF09060SV
 SF10060SV
 SF09080SV
 SF10080SV
 SF09100SV
 SF10100SV
 SF09020MV
 SF10020MV
 SF09030MV
 SF10030MV
 SF09040MV
 SF10040MV
 SF09060MV
 SF10060MV
 SF09080MV
 SF10080MV
 SF09100MV
 SF10100MV
 SF05030SV
 SF06030SV

127
  SF07030SV
 SF08030SV
 SF05040SV
 SF06040SV
 SF07040SV
 SF05060SV
 SF06060SV
 SF07060SV
 SF08060SV
 SF05080SV
 SF06080SV
 SF07080SV
 SF05100SV
 SF06100SV
 SF07100SV
 SF08100SV
 SF05120SV
 SF06120SV
 SF07120SV
 SF05150SV
 SF06150SV
 SF07150SV
 SF08150SV
 SF05200SV
 SF06200SV
 SF07200SV
 SF05030MV
 SF06030MV
 SF07030MV

132. -do- Legal Manufacturer VIKIA HIV ½ VIKIA HIV Rejected.

1/2 is a rapid The request
Evaluator: M/s. BioMérieux SA HIV(Human diagnostic test of the firm
Hafiz 376 chemin de l’Orme Immunodefi-ciency for the has been
Muhammad Asif 69280 Marcy l’Etoile – Virus) detection of acceded for
Iqbal France serum withdrawal
VIKIA HIV 1/2 antibodies to of
Manufacturering Site HIV in human application
Same as above Class D serum, plasma
Shelflife : 24 months or whole
FSC France Issued on blood.
11th December, 2017 The test is
intended for
Fee Submitted Rs. use only by
50,000/- healthcare
professionals
in laboratories
or for
decentralized
near-patient
128
 diagnostic
testing.
133. -do- Legal Manufacturer VIDAS HBs Ag Ultra Is is an Approved.
HBsAg (Hepatitis B automated
Evaluator: M/s. BioMérieux SA virus surface antigen) qualitative test
Hafiz 376 chemin de l’Orme kit kit for use on
Muhammad Asif 69280 Marcy l’Etoile – the VIDAS
Iqbal France Class D family
Shelflife : 13 months instruments
Manufacturering Site for the
M/s. BioMérieux SA detection of
376 chemin de l’Orme hepatitis B
69280 Marcy l’Etoile – surface antigen
France (HBs Ag) in
human serum
or plasma,
FSC France using the
Issued on 11th December, ELFA
2017 technique
(Enzyme
Fee Submitted Rs. Linked
50,000/- Fluorescent
Assay).

134. -do- Legal Manufacturer VIKIA HBs Ag VIKIA® Rejected.

HBs Ag (Hepatitis B HBsAg is a The request
Evaluator: M/s. BioMérieux SA virus surface antigen) qualitative test of the firm
Hafiz 376 chemin de l’Orme based on the has been
Muhammad Asif 69280 Marcy l’Etoile – VIKIA HBs Ag association of acceded for
Iqbal France monoclonal withdrawal
Class D and polyclonal of
Manufacturering Site Shelflife : 02 years antibodies application
Same as above approx.. specific to
HBsAg.
FSC France This test uses
Issued on 11th December, the principle of
2017 lateral
immunochrom
Fee Submitted Rs. atography for
50,000/- the detection
of circulating
HBs antigen. It
is used for the
detection of
the main sub-
types ad and
ay in serum,
plasma, and
whole blood
135. -do- Legal Manufacturer VIDAS anti-HCV It is an Approved.
HCV (Hepatitis C automated
Evaluator: M/s. BioMérieux SA Virus) kit qualitative test
129
 Hafiz 376 chemin de l’Orme kit for use on
Muhammad Asif 69280 Marcy l’Etoile – the
Iqbal France Class D instruments of
Shelflife : 15 months the VIDAS
Manufacturering Site family, for the
M/s. BioMérieux SA detection of
376 chemin de l’Orme IgG antibodies
69280 Marcy l’Etoile – to hepatitis C
France virus (anti-
HCV) in
FSC France human serum
Issued on 11th December, or plasma
2017 (heparin)
using the
Fee Submitted Rs. ELFA
50,000/- technique.

136. -do- Legal Manufacturer VIKIA ANTI-HCV It is a rapid Rejected.

M/s. BioMerieux SA (Anti HCV Hepatitis C test kit for the The request
Evaluator: 376 Chemin de I’Orme Virus) kit qualitative of the firm
Hafiz 69280 Marcy I’Etoile – detection of has been
Muhammad Asif France lgG antibodies acceded for
Iqbal to Hepatitis C withdrawal
Manufacturing Site: Class D Virus (anti – of
M/s. BioMerieux Shelflife : 30 months HCV) in application.
Shangai Biotech Co Ltd, human serum,
N 4633 Pusan Road, plasma, or
Kangqiao Industrial whole blood.
Park, Pudong Specifial
Economic Zone,
Shanghai 201315 – PR
China

FSC France
Issued on 18th June, 2018
Fee Submitted Rs.
50,000/-

137. -do- Legal Manufacturer HCV Real-TM Quant It is a Real- Approved.

M/s. Sacace DX Time
Evaluator: Biotechnologies s.r.l. via (HCV Hepatitis C Virus Amplification
Hafiz Santasi snc-8004-santa Quantitative) test for the
Muhammad Asif Agata,De’ Goti(BN), Italy Quantitative
Iqbal 44 22100 Como, Italy. V1-96/3FRT detection of
Manufacturing site; Hepatitis C
Via scalbirini, 44 22100 Class D Virus in
Como, Italy. Shelflife : 01 year human plasma
and the
FSC Italy simultaneous
Issued on 14th May, 2018 detection of a
HCV-specific
Fee Submitted Rs. Internal
130
 50,000/- Control (IC),
by dual
color
detection.
138. -do- Legal Manufacturer HBV Real-TM Quant It is a Real- Approved.
M/s. Sacace DX Time
Evaluator: Biotechnologies s.r.l. via (HBV Hepatitis B Virus Amplification
Hafiz Santasi snc-8004-santa Quantitative) test for the
Muhammad Asif Agata,De’ Goti(BN), Italy Quantitative
Iqbal 44 22100 Como, Italy. V5-96/3FRT detection of
Manufacturing site; Hepatitis B
Via scalbirini, 44 22100 Class D Virus in
Como, Italy. Shelflife : 01 year human plasma
and the
FSC Italy simultaneous
Issued on 14th May, 2018 detection of a
HBV-specific
Fee Submitted Rs. Internal
50,000/- Control (IC),
by dual color
detection.

139. -do- Legal Manufacturer Xpert® HIV-1 Viral It is usedin Approved.

Load conjunction
Evaluator: M/s. Cepheid 904 with clinical
Hafiz Caribbean Drive (HIV-1 VL (Human presentation
Muhammad Asif Sunnyvale, immunodeficiency and other
Iqbal CA 94089 USA virus 1 Viral Load) test laboratory
kit markers for
FSC USDFA disease
Valid till December 12, V5-96/3FRT prognosis and
2020 for use as an
Fee Submitted Rs. Class D aid in
50,000/- Shelflife : 01 year assessing viral
response to
antiretroviral
treatment as
measured by
changes in
plasma HIV-1
RNA levels

140. -do- Legal Manufacturer Xpert® HCV Viral Load Thbe Assay, Approved.
performed on
Evaluator: M/s. Cepheid 904 (HCV VL Hepatitis C GeneXpert®
Hafiz Caribbean Drive Virus Viral Load) test Instrument
Muhammad Asif Sunnyvale, kit Systems, is
Iqbal CA 94089 USA designed for
GXHCV-VL-CE-10 the rapid
FSC USDFA Valid till quantitation of
December 12, 2020 Class D Hepatitis C
Fee Submitted Rs. Shelflife : 01 year Virus (HCV)
131
 50,000/- RNA in
human
141. -do- Legal Manufacturer VIDAS HIV Duo Quick it is an Approved.
HIV (Human automated
Evaluator: M/s. BioMérieux SA immunodeficiency HIV infection
Hafiz 376 chemin de l’Orme virus) test kit screening test
Muhammad Asif 69280 Marcy l’Etoile – for use on the
Iqbal France VIDAS family
Class D instruments,
Manufacturering Site Shelflife : 01 year for the
M/s. BioMérieux SA combined
376 chemin de l’Orme detection of
69280 Marcy l’Etoile – anti-HIV-1
France (groups M and
O) and anti-
FSC France Issued on HIV-2 total
11th December, 2017 immunoglobu-
Fee Submitted Rs. lins and HIV-1
50,000/- p24 antigen in
human serum
or plasma
(lithium
heparin or
EDTA) using
the ELFA
technique
(Enzyme
Linked
Fluorescent
Assay).

142. -do- Legal Manufacturer VIDAS HBs Ag Ultra it is an Approved.

HBsAg (Hepatitis B automated
Evaluator: M/s. BioMérieux SA virus surface antigen) qualitative test
Hafiz 376 chemin de l’Orme for use on the
Muhammad Asif 69280 Marcy l’Etoile – VIDAS family
Iqbal France Class D instruments
Shelflife : 13 months for the
Manufacturering Site detection of
M/s. BioMérieux SA hepatitis B
376 chemin de l’Orme surface antigen
69280 Marcy l’Etoile – (HBs Ag) in
France human serum
or plasma,
FSC France Issued on using the
11th December, 2017 ELFA
Fee Submitted Rs. technique
50,000/- (Enzyme
Linked
Fluorescent
Assay).

132
143. -do- Legal Manufacturer VIDAS anti-HCV it is an Approved.
HCV (Hepatitis C automated
Evaluator: M/s. BioMérieux SA Virus) test kit qualitative test
Hafiz 376 chemin de l’Orme for use on the
Muhammad Asif 69280 Marcy l’Etoile – instruments of
Iqbal France Class D the VIDAS
Shelflife : 15 months family, for the
Manufacturering Site detection of
M/s. BioMérieux SA IgG antibodies
376 chemin de l’Orme to hepatitis C
69280 Marcy l’Etoile – virus (anti-
France HCV) in
human serum
FSC France Issued on or plasma
11th December, 2017 (heparin)
using the
ELFA
technique
(Enzyme
Linked
Fluorescent
Assay). The
detection of
these specific
antibodies, in
conjunction
with other
clinical
information,
aids in the
diagnosis of
infection in
persons with
symptoms of
hepatitis and
in persons at
risk for
hepatitis C
infection.

144. -do- Legal Manufacturer : FilmArray® The FilmArray Approved.

Respiratory Panel 2 RP2plus pouch
Evaluator: M/s. BioFire plus (RP2plus) is a closed
Hafiz Diagnostics, LLC, 515 system
Muhammad Asif Colorow Drive, RFIT-ASY-0136 disposable that
Iqbal Salt Lake City, UT 84108 RFIT-ASY-0137 houses all the
USA. chemistry
Class C required to
FSC USFDA Valid till Shelflife : 12 months isolate,
December 04, 2019 amplify, and
Fee Submitted Rs. detect nucleic
50,000/- acid from 22
133
 different
respiratory
pathogens
from a single
NPS specimen
in
approximately
45 minutes.

145. -do- Legal Manufacturer : EIAgen HCV Ab (v.4) Fourth Approved.

(HCV Ab – Hepatitis C generation
Evaluator: M/s. Adaltis S.r.l. Virus Antibody) test kit enzyme linked
Hafiz Via Durini, 27 – 20122 immunosorbe
Muhammad Asif Milano – Italy \Codes: nt assay
Iqbal 071067 (ELISA) for the
Manufacturing Site: 071064 determination
071068 of antibodies
M/s. Adaltis S.r.l. to Hepatitis C
Via Luigi Einaudi, 7 – Class D Virus in
00012 Guidonia Shelflife : 15 months human plasma
Montecelio (Roma) – (EDTA,
Italy (Production, Heparin, &
Warehouse, & shipment) Citrate) and
Via Andrea Costa, 2 – sera. The kit
40134 Bologna – Italy may be used
for the
FSC Italy Issued on 13th screening of
March, 2018 blood units of
HCV-infected
Fee Submitted Rs. patients.
50,000/- For invitro
diagnostic use
only.
146. -do- Legal Manufacturer : Xpert® CT/NG The Assay, Approved.
(chlamydial performed on The FSC is
Evaluator: Cepheid AB trachomatis / Neisseria the valid till
Hafiz Röntgenvägen 5, SE-171 gonorrheal) test kit GeneXpert® 2020.
Muhammad Asif 54 Instrument
Iqbal Solna, Sweden Codes: System, are
GXCT/NG-CE-10 qualitative in
FSC Sweden Valid until GXCT/NG-CE-120 vitro real-time
December 12, 2018 PCR tests for
Class C the automated
Shelflife : 24 months and rapid
detection and
differentiation
of genomic
DNA from
Chlamydia
trachomatis
(CT) and
Neisseria
134
 gonorrhoeae
(NG) to aid in
the diagnosis
of chlamydial
and/or
gonorrheal
urogenital
disease.
147. -do- Legal Manufacturer : FilmArray® The FilmArray Approved
Gastrointestinal (GI) GI pouch is a subject
Evaluator: M/s. BioFire Panel closed system provision of
Hafiz Diagnostics, LLC, 515 disposable to differential
Muhammad Asif Colorow Drive, Codes: that houses all fee of Rs.
Iqbal Salt Lake City, Utah RFIT-ASY-0104 the chemistry 25000/- and
84108 RFIT-ASY-0116 required to the Class is
USA. isolate, classified as
Class B amplify, and C instead of
detect nucleic
FSC USFDA Shelflife : 12 months B.
acid using a
Valid till December 04,
combination
2019 of genus level
assays that
detect a broad
range of
organisms,
species-
specific assays,
and assays for
specific
virulence
markers (e.g.
toxin genes).

148. -do- Legal Manufacturer : FilmArray® The FilmArray Approved.

Pneumonia Panel plus Pneumonia
Evaluator: M/s. BioFire (Test kit) Panel plus
Hafiz Diagnostics, LLC, 515 pouch is a
Muhammad Asif Colorow Drive, Codes: RFIT-ASY-0142 closed system
Iqbal Salt Lake City, Utah RFIT-ASY-0143 disposable
84108 that houses all
USA. Class C the chemistry
Shelflife : 12 months required to
isolate,
FSC USFDA
amplify, and
Valid till December 04,
detect nucleic
2019 acid from
lower
respiratory
pathogens
within a single
sputum-like or
BAL-like
specimen. The
135
 rigid plastic
component
(fitment) of the
FilmArray
Pneumonia
Panel plus
pouch
contains
reagents in
freeze-dried
form.
149. -do- Legal Manufacturer : Transfer Grifols Blood bag Approved.
(Transfer Blood Bags) without
Evaluator: M/s. Laboratory Grifols, anticoaggulant
Hafiz S.A,: Poligono Levante. - Transfer Grifols 150
Muhammad Asif C/Can Guasch, 2. - Transfer Grifols 300
Iqbal Industrial 08150 Parets - Transfer Grifols 400
del Valles (Barcelona) - Transfer Grifols 600
Spain. -

Manufacturing Site: Class C

1. PASSEIG Fluvial, 24 Shelflife : 05 years
Polingono Industrial
Autopista-08150-
Parets dEl valles
(Barcelona) Spain.
2. Avenida Juan Carlos
I, 97 -30565- Las
Torres De Cotillas
(Murcia) Spain.
3. Poligono Industrial
Los Llanos C/Martte,
4-30565-Las Torres
De Cotillas (Murcia)
Spain.

FSC Spain
Valid till 08-01-2020
150. -do- Legal Manufacturer : CPD Adenine Grifols CPD Adenine Approved.
M/s. Laboratory Grifols, (Blood Bags containing Grifols are
Evaluator: S.A,: Poligono Levante. anti-coagulant Citrate blood bags
Hafiz C/Can Guasch, 2. Phosphat Dextrose containing
Muhammad Asif Industrial 08150 Parets Adenine) CPD-A as an
Iqbal del Valles (Barcelona) anti-
Spain. CPD Adenine Grifols coagulannt.
Single S.K. CPD intended
Manufacturing Site: CPD Adenine Grifols to be used for
4. PASSEIG Fluvial, 24 Double S.K. the extraction,
Polingono Industrial CPD Adenine Grifols fractionatioon,
Autopista-08150- Triple S.K. preservation,
Parets dEl valles CPD Adenine Grifols and
(Barcelona) Spain. Quadruple S.K. transfusion of

136
 5. Avenida Juan Carlos blood.
I, 97 -30565- Las Class D
Torres De Cotillas Shelflife : 04 years
(Murcia) Spain.
6. Poligono Industrial
Los Llanos C/Martte,
4-30565-Las Torres
De Cotillas (Murcia)
Spain.

FSC Spain
Valid till 08-01-2020
151. -do- Legal Manufacturer : FilmArray® The FilmArray Approved.
Meningitis/Encephaliti ME pouch is a
Evaluator: M/s. BioFire s (ME) Panel closed system
Hafiz Diagnostics, LLC, 515 disposable that
Muhammad Asif Colorow Drive, houses all the
Iqbal Salt Lake City, Utah Codes: chemistry
84108 RFIT-ASY-0119 required to
USA. RFIT-ASY-0118 isolate,
amplify, and
FSC USFDA detect nucleic
Valid till December 04, Class C acid using a
2019 Shelflife : 01 year combination of
assays that
detect a broad
range of
organisms.
152. -do- Legal Manufacturer : FilmArray® Blood The FilmArray Approved
Culture Identification BCID pouch is subject to
Evaluator: M/s. BioFire (BCID) Panel a closed provision of
Hafiz Diagnostics, LLC, 515 system differential
Muhammad Asif Colorow Drive, Codes: disposable fee of Rs.
Iqbal Salt Lake City, Utah RFIT-ASY-0127 that houses all 25000/- and
84108 RFIT-ASY-0126 the chemistry the Class is
USA. required to classified as
Class B isolate, C instead of
Shelflife : 04 months amplify, and
FSC USFDA B.
detect nucleic
Valid till December 04,
acid using a
2019 combination
of assays to
identify
individual
species as well
as groups of
organisms at
the family,
genus,
complex,
and/or species
level.
153. M/s. Intek Legal Manufacturer Temporary The temporary Approved
137
 Corporation, M/s. HAGMED sp. z transvenous pacing transvenous subject to
Office No. 30, Al- o.o. sp.k. UI. electrode: pacing foreign
Amin Plaza, The Tomaszowska 32, electrode is inspection
Mall, 96-200 Rawa Size Varainats: used for abroad. The
Rawalpindi. Mazowiecka, Poland. temporary Board also
ES1Z ESM3Z transvenous authorized
(ELI-00034) FSC Poland ES2Z ESM4Z pacing (up to 2 the Secretary
Issued on 28th ES3Z ESM1J weeks) mainly MDB to issue
November, 2018 ES4Z ESM2J for registration
Evaluator: ES1J ESM3J reanimation of of product if
Muhammad Rs. 50,000 ES2J ESM4J patients with the
Ayub Naveed ES3J ESM1P sudden manufacturin
ES4J ESM2P ventricular g plant is
ES1P ESM3P arrest. It can be approved by
ES2P ESM4P used in the panel of
ES3P ESB1 present or experts.
ES4P ESB2 threatening
ESM1Z ESB3 bradycardia
ESM2Z ESB4 caused by
conduction
Class D system disease
Shelf Life : 04 years or acute
myocardial
infarction.
Indication for
use may be
treatments,
during which
may occur a
clinically
significant
decrease of
heart rate, as
well as need to
manage
recurrent,
dangerous
ventricular
arrhythmias.
The electrode
is disposable,
sterile, non-
toxic, pyrogen
free, and it is
detectable
under
fluoroscopy.
154. -do- Legal manufacturer Teleport Micro Catheter Approved.
OrbusNeich Medical MicroCatheter
Evaluator: B.V., (Micro Catheter)
Muhammad Address: Drs. W. Van
Ayub Naveed Royenstraat 5, 3871 AN Size Variants:
138
 Hoevelaken, the 220 -13-2000
Netherlands. 220 -15-2000
221 -13-2000
FSC Netherland 221 -15-2000
Valid until March 5, 2023
Class D
Fee Submitted Rs. Shelf Life : 02 years
50,000/-

155. -do- Legal manufacturer Combo Plus Dual The COMBO Approved.
OrbusNeich Medical Therapy Stent Plus stent
Evaluator: B.V., Delivery System system is a
Muhammad Address: Drs. W. Van (Stent Delivery System) coronary
Ayub Naveed Royenstraat 5, 3871 AN balloon
Hoevelaken, the Size Variants: expandable
Netherlands. 225-092-11 225-232-11 stent which
227-092-11 227-232-11 consist of a
FSC Netherland 230-092-11 230-232-11 316L stainless
Valid until March 5, 2023 235-092-11 235-232-11 steel alloy
240-092-11 240-232-11 coated with a
Fee Submitted Rs. 225-132-11 225-282-11 biocompatible,
50,000/- 227-132-11 227-282-11 biodegradable
230-132-11 230-282-11 polymer
235-132-11 235-282-11 containing
240-132-11 240-282-11 sirolimus (also
225-152-11 225-332-11 known as
227-152-11 227-332-11 rapamycin).
230-152-11 230-332-11 Covalently
235-152-11 235-332-11 attached to
240-152-11 240-332-11 this matrix is a
225-182-11 230-382-11 layer of
227-182-11 235-382-11 murine,
230-182-11 240-382-11 monoclonal,
235-182-11 anti-human
240-182-11 CD34
antibody.
Class D
Shelf Life : 538 days

156. -do- Manufacturer/ Traxcess 14 Guidewire Guidewire Approved.

Manufacturing Site:
Evaluator: i) M/s Microvention, Class D
Hafiz Inc., 1311 Valencia
Shelf Life: 3 Years
Muhammad Asif Avenue Tustin, CA
Iqbal 92780, USA
Codes & Sizes as per
FSC.
ii) M/s Ashitaka Factory
of Terumo Corp., 150
Maimaigi-Cho
Fujinomiya, Sizuoka 418-
0015, Japan
139
 (FSC USFDA Valid Till
31-08-2019)

Fee Submitted Rs.

50,000/-

157. -do- Legal Manufacturer SOFIA PLUS Sophia Plus is Approved.

Microvention Europe: Percutaneous Catheter intravascular
Evaluator: 30 bis rue du Vieli (Distal Access + distal
Hafiz Abreuvior, 78100 Saint Aspiration) access/guidin
Muhammad Asif Germain e Laye, France g catheter and
Iqbal Size Variants: can be used for
Production Sites DA6125ST clot aspiration
MicroVension,Inc. DA6131ST and delivery of
1311 Valencia Avenue DA6135ST stent, balloon,
Tustin, California, 92780 flow diverters,
USA Class D retrieval
Shelflife : 03 years devices etc.
MicroVension Inc.
35 Enterprise, Aliso
Viejo,
CA 92656, USA

MicroVension Costa Rica

S.R.L Edificio B33
Zona Franca Coyol
Alajuela, Costa Rica

FSC France
Issued on 18th January,
2018

Fee Submitted Rs.

50,000/-

158. M/s. Nisa Impex Legal manufacturer Nisa IV Cannula Intra venous Approved
(Private) Ltd., M/s. Chengdu Xinjin Disposable subject to
Maxim Arcade, Shifeng Medical Sizes: Cannula foreign
Plot No. 13-14, Apparatus & Instrument 0.7 x19, 0.9x19,0.9x258, inspection
Usman Block, Co. Ltd., No. 46, 7th 1.1 x 32, 1.1 x 38, 1.3 x abroad. The
Jeddah Town, Group, Wanjie Village, 45, 1.6x 38, 1.6x45, Board also
Phse I, Opp: Xinping Town, Xinjin 2.1x38, 2.1x45 authorized
DHA-II, G.T. County, Chengdu City, the Secretary
Road, Islamabad. P.R. China. Class B MDB to issue
Shelf Life : 05 years registration
(ELI-00064) FSC China of product if
Valid until March 27, the
Evaluator: 2020 manufacturin
Muhammad g plant is
Ayub Naveed Rs. 100,000 approved by
(Already submitted on the panel of
140
 15-3-2016) experts.

159. -do- Legal manufacturer Nisa Blood Transfusion Blood Approved

M/s. Chengdu Xinjin Set Transfusion subject to
Evaluator: Shifeng Medical Set foreign
Muhammad Apparatus & Instrument Sizes: inspection
Ayub Naveed Co. Ltd., No. 46, 7th 0.7, 0.8, 0.9 & 1.2 abroad. The
Group, Wanjie Village, Board also
Xinping Town, Xinjin Class B authorized
County, Chengdu City, Shelf Life : 05 years the Secretary
P.R. China. MDB to issue
registration
FSC China of product if
Valid until June 6, 2019 the
manufacturin
Rs. 100,000 (Already g plant is
submitted) approved by
the panel of
experts.
160. -do- Legal manufacturer Nisa Wound Plast Wound Plast Approved
M/s. Chengdu Xinjin (Wound Plast) subject to
Evaluator: Shifeng Medical foreign
Muhammad Apparatus & Instrument Sizes: inspection
Ayub Naveed Co. Ltd., No. 46, 7th 60x30, 70x18, 70x35, abroad. The
Group, Wanjie Village, 70x45, 70x60, 70x90, Board also
Xinping Town, Xinjin 70x110, 80x50, 80x120 authorized
County, Chengdu City, the Secretary
P.R. China. Class B MDB to issue
Shelf Life : 05 years registration
FSC China of product if
Valid until March 27, the
2020 manufacturin
g plant is
Rs. 100,000 (Already approved by
submitted) the panel of
experts.

161. -do- Legal manufacturer Nisa Stomach Tube Stomach Tube Approved
M/s. Chengdu Xinjin subject to
Evaluator: Shifeng Medical Sizes: foreign
Muhammad Apparatus & Instrument 5F,6F, 8F, 12F, 14F, 16F, inspection
Ayub Naveed Co. Ltd., No. 46, 7th 18F, 20F, 22F, 24 F abroad. The
Group, Wanjie Village, Board also
Xinping Town, Xinjin Class B authorized
County, Chengdu City, Shelf Life : 05 years the Secretary
P.R. China. MDB to issue
registration
FSC China of product if
Valid until March 27, the
2020 manufacturin
g plant is
141
 approved by
Rs. 100,000 (Already the panel of
submitted) experts.

162. -do- Legal manufacturer Nisa Scalp Vain Set Scalp Vain Set Approved
M/s. Chengdu Xinjin subject to
Evaluator: Shifeng Medical Sizes: foreign
Muhammad Apparatus & Instrument 14G - 27 G inspection
Ayub Naveed Co. Ltd., No. 46, 7th abroad. The
Group, Wanjie Village, Class B Board also
Xinping Town, Xinjin Shelf Life : 05 years authorized
County, Chengdu City, the Secretary
P.R. China. MDB to issue
registration
FSC China of product if
Valid until March 27, the
2020 manufacturin
g plant is
Rs. 100,000 (Already approved by
submitted) the panel of
experts.

163. M/s. Digital Legal Manufacturer / AMPLATZER Sizing Cardiac Approved.

Imaging Manufacturing Site: Balloon Balloon
Systems, 121- M/s. AGA Medical (Cardiac Catheter, Catheter
Habitat Corporation, Balloon, Sizing)
Apartments, 5050 Nathan Lane North,
Shadman II, Plymouth, Minnesota, 9-SB-018, 9-SB-024,
Ghaus -ul-Azam 55442, USA 9-SB-034,
Road, Lahore,
Lahore FSC Belgium Class D
Issued on 06-12-2018 Shelf Life: 3 years
(ELI-00094)
Fee Submitted Rs.
Evaluator: 50,000/-
Muhammad
Ayub Naveed
164. -do- Legal Manufacturer: AMPLATZER Septal Atrial Septal Approved.
M/s. AGA Medical Occluder Defects (ASD)
Evaluator: Corporation, Occluder
Muhammad 5050 Nathan Lane North, 9-ASD-004, 9-ASD-005, .
Ayub Naveed Plymouth, Minnesota, 9-ASD-006,
55442, USA 9-ASD-007, 9-ASD-
008,9-ASD-009,
FSC Belgium 9-ASD-010, 9-ASD-011,
Issued on 06-12-2018 9-ASD-012,
9-ASD-013,9-ASD-014,
Fee Submitted Rs. 9-ASD-015,
50,000/- 9-ASD-016, 9-ASD-017,
9-ASD-018,
9-ASD-019, 9-ASD-020,
9-ASD-022,
142
 9-ASD-024, 9-ASD-
026,9-ASD-028,
9-ASD-030, 9-ASD-032,
9-ASD-034,
9-ASD-036,9-ASD-038,
9-ASD-040,

Class D
Shelf Life: 5 years
165. -do- Legal Manufacturer: AMPLATZER Coronary Approved.
M/s. AGA Medical Guidewires Guidewire
Evaluator: Corporation, (Catheter Guidewire)
Muhammad 5050 Nathan Lane North,
Ayub Naveed Plymouth, Minnesota, 9-GW-001, 9-GW-002,
55442, USA 9-GW-003, 9-GW-004

FSC Belgium Class D

Issued on 06-12-2018 Shelf Life: 5 years

Fee Submitted Rs.

50,000/-

166. -do- Legal Manufacturer: Amplatzer Multi Atrial Septal Approved.

M/s. AGA Medical Fenestrated Septal Defects (ASD)
Evaluator: Corporation, Occluder ‘Cribriform’ Occluder
Muhammad 5050 Nathan Lane North, (Cardiac Occluder)
Ayub Naveed Plymouth, Minnesota,
55442, USA 9-ASD-MF-018, 9-ASD-
MF-025,
FSC Belgium 9-ASD-MF-030, 9-ASD-
Issued on 06-12-2018 MF-035,
9-ASD-MF-040
Fee Submitted Rs.
50,000/- Class D
Shelf Life: 5 years

167. -do- Legal Manufacturer: Amplatzer PFO PFO Occluder Approved.

M/s. AGA Medical Occluder
Evaluator: Corporation,
Muhammad 5050 Nathan Lane North, 9-PFO-018, 9-PFO-025,
Ayub Naveed Plymouth, Minnesota, 9-PFO-030, 9-PFO-035
55442, USA
Class D
FSC Belgium Shelf Life: 5 years
Issued on 06-12-2018

Fee Submitted Rs.

50,000/-

168. -do- Legal Manufacturer / Amplatzer TorqVue Cardiac Approved.

143
 Manufacturing Site: Exchange System Occulder
Evaluator: M/s. AGA Medical (Cardiac Occulder delivery kit
Hafiz Corporation, delivery kit)
Muhammad Asif 5050 Nathan Lane North,
Iqbal Plymouth, Minnesota, 9-EITV09F45/80,
55442, USA 9-EITV12F45/80,
9-EITV06F180/80,
FSC Belgium 9-EITV08F180/80,
Issued on 07-12-2018 9-EITV10F180/80

Fee Submitted Rs. Class D

50,000/- Shelf Life: 3 years

169. -do- Legal Manufacturer / Amplatzer Duct PDA Occluder Approved.

Manufacturing Site: Occluder II (Cardiac
Evaluator: M/s. AGA Medical Occulder)
Hafiz Corporation,
Muhammad Asif 5050 Nathan Lane North, 9-PDA2-03-04,
Iqbal Plymouth, Minnesota, 9-PDA2-04-04,
55442, USA 9-PDA2-05-04,
9-PDA2-06-04,
FSC Belgium 9-PDA2-03-06,
Issued on 07-12-2018 9-PDA2-04-06
9-PDA2-05-06,
Fee Submitted Rs. 9-PDA2-06-06,
50,000/- 9-PDA2AS-03-02-L,
9-PDA2AS-03-04-L,
9-PDA2AS-03-06-L,
9-PDA2AS-04-02-L,
9-PDA2AS-04-04-L,
9-PDA2AS-04-06-L,
9-PDA2AS-05-02-L,
9-PDA2AS-05-04-L,
9-PDA2AS-05-06-L

Class D
Shelf Life: 5 years

170. -do- Legal Manufacturer / Amplatzer TorqVue Cardiac Approved.

Manufacturing Site: Delivery System Occulder
Evaluator: M/s. AGA Medical (Cardiac Occulder delivery kit.
Hafiz Corporation, delivery kit)
Muhammad Asif 5050 Nathan Lane North,
Iqbal Plymouth, Minnesota, 9-ITV06F45/60,
55442, USA 9-ITV07F45/60,
9-ITV08F45/60,
FSC Belgium 9-ITV07F45/80,
Issued on 07-12-2018 9-ITV08F45/80,
274-R&I 12.03.2019 9-ITV09F45/80
Rs. 50,000 9-ITV10F45/80,
89-P-DD(MD) 28-03- 9-ITV12F45/80,
144
 2019 9-ITV13F45/80,
Fee Submitted Rs. 9-ITV05F180/60,
50,000/- 9-ITV06F180/60,
9-ITV06F180/80
9-ITV07F180/80,
9-ITV08F180/80,
9-ITV09F180/80

Class D
Shelf Life: 3 years

171. -do- Legal Manufacturer / Amplatzer TorqVue Cardiac Approved.

Manufacturing Site: LP Delivery System Occulder
Evaluator: M/s. AGA Medical (Cardiac Occulder delivery kit
Hafiz Corporation, delivery kit)
Muhammad Asif 5050 Nathan Lane North,
Iqbal Plymouth, Minnesota, 9-TVLP4F90/060,
55442, USA 9-TVLP4F90/080,
9-TVLP5F90/060,
FSC Belgium 9-TVLP4F90/080
Issued on 07-12-2018
Class D
Fee Submitted Rs. Shelf Life: 3 years
50,000/-

172. -do- Legal Manufacturer / Amplatzer Muscular VSD Occulder Approved.

Manufacturing Site: VSD Occluder
Evaluator: M/s. AGA Medical (Cardiac Occulder)
Hafiz Corporation,
Muhammad Asif 5050 Nathan Lane North, 9-VSD-MUSC-004,
Iqbal Plymouth, Minnesota, 9-VSD-MUSC-006,
55442, USA 9-VSD-MUSC-008,
9-VSD-MUSC-010,
FSC Belgium 9-VSD-MUSC-012,
Issued on 07-12-2018 9-VSD-MUSC-014,
9-VSD-MUSC-016,
Fee Submitted Rs. 9-VSD-MUSC-018,
50,000/-
Class D
Shelf Life: 5 years

173. -do- Legal Manufacturer / Amplatzer Duct Duct Occluder Approved.

Manufacturing Site: Occluder
Evaluator: M/s. AGA Medical (Cardiac Occulder)
Hafiz Corporation,
Muhammad Asif 5050 Nathan Lane North, 9-PDA-003, 9-PDA-004,
Iqbal Plymouth, Minnesota, 9-PDA-005, 9-PDA-006,
55442, USA 9-PDA-007, 9-PDA-008,
9-PDA-009
FSC Belgium
Issued on 07-12-2018 Class D
Shelf Life: 5 years
145
 Fee Submitted Rs.
50,000/-

174. -do- Legal Manufacturer / Amplatzer VSD Occluder Approved.

Manufacturing Site: Memberanous VSD
Evaluator: M/s. AGA Medical Occluder
Hafiz Corporation, (Cardiac Occulder)
Muhammad Asif 5050 Nathan Lane North,
Iqbal Plymouth, Minnesota, 9-VSD-MEMB-004,
55442, USA 9-VSD-MEMB-005,
9-VSD-MEMB-006,
FSC Belgium 9-VSD-MEMB-007,
Issued on 07-12-2018 9-VSD-MEMB-008,
9-VSD-MEMB-009,
Fee Submitted Rs. 9-VSD-MEMB-010,
50,000/- 9-VSD-MEMB-011,
9-VSD-MEMB-012,
9-VSD-MEMB-013,
9-VSD-MEMB-014,
9-VSD-MEMB-015,
9-VSD-MEMB-016,
9-VSD-MEMB-017,
9-VSD-MEMB-018

Class D
Shelf Life: 5 years
175. -do- Legal Manufacturer / Amplatzer Vascular Embolization Approved.
Manufacturing Site: Plug Implant,
Evaluator: M/s. AGA Medical (Embolization Implant, Vascular
Hafiz Corporation, Vascular)
Muhammad Asif 5050 Nathan Lane North,
Iqbal Plymouth, Minnesota, 9-PLUG-004, 9-PLUG-
55442, USA 006,
9-PLUG-008, 9-PLUG-
FSC Belgium 0010,
Issued on 07-12-2018 9-PLUG-012, 9-PLUG-
014,
Fee Submitted Rs. 9-PLUG-016,
50,000/-
9-AVP2-003, 9-AVP2-
004,
9-AVP2-006, 9-AVP2-
008,
9-AVP2-010, 9-AVP2-
012,
9-AVP2-014, 9-AVP2-
016,
9-AVP2-018, 9-AVP2-
020,
9-AVP2-022,

9-AVP3-042, 9-AVP3-
146
 063,
9-AVP3-084, 9-AVP3-
103,
9-AVP3-105, 9-AVP3-
123,
9-AVP3-125, 9-AVP3-
143,
9-AVP3-145,

9-AVP038-004, 9-
AVP038-005, 9-
AVP038-006, 9-
AVP038-007, 9-
AVP038-008

Class C
Shelf Life: 5 years

176. -do- Legal Manufacturer / Amplatzer PI Muscular VSD Occluder Approved.

Manufacturing Site: VSD Occluder
Evaluator: M/s. AGA Medical (Cardiac Occulder)
Hafiz Corporation,
Muhammad Asif 5050 Nathan Lane North, 9-VSDMUSCPI-016,
Iqbal Plymouth, Minnesota, 9-VSDMUSCPI-018,
55442, USA 9-VSDMUSCPI-020,
9-VSDMUSCPI-022,
FSC Belgium 9-VSDMUSCPI-024
Issued on 07-12-2018
Class D
Shelf Life: 5 years
Fee Submitted Rs.
50,000/-

177. M/s. K.M. M/s. Karex Industries Carex Male Latex Latex Male Approved
Enterprises, Sdn. Bhd., PTD., Condom Condom subject to
605-D-Block, Malaysia foreign
M.A. Johar FSC Malaysia valid till P53S – Natural inspection
Town, Lahore. 11th May, 2019 Length: Min 180 mm abroad. The
(ELI-00054) without teat Board also
Width :53 ±2 mm authorized
Evaluator: Rs. 50,000 Fee already Thickness : 0.065 mm the Secretary
Muhammad submitted with (+0.015mm, - 0.020 mm) MDB to issue
Ayub Naveed documents dated 10th Lubricant details : 0.55g registration
March, 2017 ±0.15g of product if
the
Class D manufacturin
Shelflife : 03 years g plant is
approved by
the panel of
experts.
178. -do- Manufacturer/ Euro-Ject (Disposable Sterile, single- Approved
Manufacturing Site: Syringe) use syringe subject to
147
 Evaluator: M/s. Euromed for foreign
Unum Zia Medical Industries, 1ml, 3ml, 5ml, 10ml inspection
Shamsi Area No. 10, Block (i) abroad. The
Free Zone, Nasr City, Class B Board also
Cairo Egypt. authorized
05 years the Secretary
FSC Egypt Issue date MDB to issue
06-03-2018 registration
Fee submitted: Rs. of product if
25,000 the
manufacturin
g plant is
approved by
the panel of
experts. Sizes
demanded
on Form-7A
shall be
granted.

Sizes not on
free sale
certificate

179. M/s. Unique M/s. Shanghai Kindly Easy Pro Disposable Disposable Approved.
Pharma, Enterprise Development Syringe Syringe
House No. Group Co., Ltd., 658,
1775/21, Street Gaochao Road, 1ml,2ml,2.5ml,3ml,5ml,
No. 1, Tariqabad, Shanghai, 201803, China 10ml,20ml,25ml,30ml,3
MDA Road, 5ml,50ml,60ml
Multan. FSC China
Valid till 18.01.2020 Class B
(ELI-00068) Shelf Life : 05 years
Also provided
Evaluator: FSC Germany
Muhammad Issued on 06.11.2018
Ayub Naveed

Fee submitted Rs. 25,000

180. -do- M/s. Shanghai Kindly Hypodermic Needles Hypodermic Approved.

Enterprise Development Needle
Evaluator: Group Co., Ltd., 658, 0.3,0.33,0.36,0.4,0.45,0.5,
Muhammad Gaochao Road, 0.55,0.6,0.7,0.8,0.9,1.1,1.
Ayub Naveed. Shanghai, 201803, China 2

FSC China Class B

Valid till 18.01.2020 Shelf Life : 05 years

Also provided
148
 FSC Germany
Issued on 06.11.2018

Fee submitted Rs. 25,000

181. -do- M/s. Shanghai Kindly “Uni-Set” Infusion Set IV Infusion Approved.
Enterprise Development Sets
Evaluator: Group Co., Ltd., 658, IVA002,IVA004,IVA008
Muhammad Gaochao Road,
Ayub Naveed. Shanghai, 201803, China Class B
Shelf Life : 05 years
FSC China Valid till
18.01.2020

Also provided FSC

Germany Issued on
06.11.2018

Fee submitted Rs. 25,000

182. -do- M/s. Shanghai Kindly “Uni-Set” Infusion Set Approved.

Enterprise Development IVA002,IVA004,IVA008 with Burette
Evaluator: Group Co., Ltd., 658,
Muhammad Gaochao Road, Class B
Ayub Naveed. Shanghai, 201803, China Shelf Life : 05 years

FSC China Valid till

18.01.2020

Also provided FSC

Germany Issued on
06.11.2018

Fee submitted Rs. 25,000

183. M/s BSN Manufacturer: Cutimed® Sorbact® Non – Approved.

Medical (Pvt) M/s BSN Medical Hydroactive adhesive gel
Ltd., A/69, SITE GmbH, Quickbornstrabe dressing with
Manghopir 24, 20253 Hamburg, Class C Bacteria-
Road, Karachi Germany binding action.
Shelf Life: 3 Years
(ELI-00011)
(FSC Germany Issuance Codes & Sizes as per
Evaluator: Date 23-10-2018) FSC of Germany
Muhammad
Ayub Naveed Fee Rs.50,000/-

184. M/s Zenith Manufacturer: Perfect Piston Nebulizer is Approved

International, M/s Shenzhen Homed intend for use subject to
Compressor Nebulizer
Room No. 104, Medical Device Co. Ltd., in the foreign
Tahir Plaza, 3rd Floor, Block1, Class B treatment of inspection
149
 A/20, Block 7&8, Longquan Industrial Shelf Life: Not asthma, COPD abroad. The
KCHSU, Karachi Zone, Huarong Road, and other Board also
Applicable
Dalang Street, Longhua respiratory authorized
(ELI-00090) New District, Shenzhen ailments in the Secretary
518109, PR China which an MDB to issue
aerosolized registration
(FSC China Valid Till medication is of product if
19-10-2019) required the
during therapy manufacturin
Fee submitted Rs. g plant is
25,000/- approved by
the panel of
experts.
185. -do- Manufacturer: Perfect Disposable Disposable Approved
M/s Tianchang Sterile Latex Surgical Latex Surgical subject to
Evaluator: Hengsheng Medical Gloves Gloves, Sterile foreign
Muhammad Devices Co. Ltd., Qinlan is used during inspection
Ayub Naveed Industrial Park Class B Surgical abroad. The
Tianchang City, Anhui Operations to Board also
Shelf Life: 5 Years
Province, China Protect patient authorized
6, 6.5, 7, 7.5, 8, 8.5, 9 and user, may the Secretary
(FSC China Valid Till prevent cross MDB to issue
18-03-2020) infection registration
of product if
Fee submitted Rs. the
25,000/- manufacturin
g plant is
approved by
the panel of
experts.

186. M/s Hospicare Manufacturer: Hemotherm 400CE® Hemotherm Approved.

Systems, M/s Cincinnati Sub-Zero Dual Reservoir 400 CE
Mezzanine Floor, Products, LLC 12011 Cooler / Heater Heater/
Rabbiya Garden, Mosteller Road System Cooler System
Block 3, MCHS, Cincinnati, OH 45241, Class C
Shaheed-e-Millat USA
Road, Karachi Shelf Life: 12 Years
(FSC USFDA Valid Till
(ELI-00274) 19-07-2019) Model: 400CE®

Evaluator: Fee Submitted

Muhammad Rs.50,000/-
Ayub Naveed
187. -do- Manufacturer: Warm Air® Model 135 Warm Air Approved.
M/s Cincinnati Sub-Zero Convective Warming System
Evaluator: Products, LLC 12011 System
Muhammad Mosteller Road
Ayub Naveed Cincinnati, OH 45241, Class C
USA
Shelf Life: 7 Years
(FSC USFDA Valid Till
150
 19-07-2019)

Fee Submitted
Rs.50,000/-

188. -do- Manufacturer: Norm-O-Temp Model Norm-O-Temp Approved.

M/s Cincinnati Sub-Zero 111W Hyperthermia Hyperthermia
Evaluator: Products, LLC 12011 System and Accessories System
Muhammad Mosteller Road Including Blankets and
Ayub Naveed Cincinnati, OH 45241, Pads.
USA
Class C
(FSC USFDA Valid Till
19-07-2019) Shelf Life: 10 Years
Fee Submitted
Rs.50,000/-

189. -do- Manufacturer: Blanketrol III Model Blanketrol III Approved.

M/s Cincinnati Sub-Zero 233 Hyper/Hypert
Evaluator: Products, LLC 12011 Hyper/Hypothermia hermia System
Muhammad Mosteller Road System and Accessories
Ayub Naveed Cincinnati, OH 45241,
USA Class C

(FSC USFDA Valid Till Shelf Life: 12 Years

19-07-2019)

Fee Submitted
Rs.50,000/-

190. M/s Premier Legal Manufacturer: BD Micro-Fine TM + Pen BD Micro-Fine Approved.

TM
Agencies, 60, M/s Becton Dickson and Needle + Pen
Muslimabad, Company 1 Becton Needle is a
Jamshed Drive, Franklin Lakes NJ Class B sterile single
Quarters, M.A. 07417, USA use device
Shelf Life: 5 Years
Jinnah Road designed for
Extension, Manufacturing Site: the parenteral
BD Micro-Fine TM + Pen
Karachi M/s Becton Dickinson administration
Needle 0.25MM (31G) *
Medical (S) PTE Ltd., 30 of a drug.
8MM
(ELI-00050) TUAS Avenue 2,
Singapore
Evaluator:
Muhammad (FSC Singapore Valid Till
Ayub Naveed 23-01-2019)
Fee Submitted
Rs.25,000/-

191. -do- Legal Manufacturer: BD Micro-Fine TM + Pen BD Micro-Fine Approved.

TM
M/s Becton Dickson and Needle + Pen
Evaluator: Company 1 Becton Needle is a
Muhammad Drive, Franklin Lakes NJ Class B sterile single
Ayub Naveed 07417, USA use device
151
 Shelf Life: 5 Years designed for
Manufacturing Site: the parenteral
M/s Becton Dickinson BD Micro-Fine TM + Pen administration
Medical (S) PTE Ltd., 30 Needle 0.23MM (32G) * of a drug.
TUAS Avenue 2, 4MM
Singapore

(FSC Singapore Valid Till

23-01-2019)

(FSC Ireland Valid Till

23-11-2022)
Fee Submitted
Rs.25,000/-
192. -do- Legal Manufacturer: BD Micro-Fine TM + Pen BD Micro-Fine Approved.
TM
M/s Becton Dickson and Needle + Pen
Evaluator: Company 1 Becton Needle is a
Muhammad Drive, Franklin Lakes NJ Class B sterile single
Ayub Naveed 07417, USA use device
Shelf Life: 5 Years
designed for
Manufacturing Site: the parenteral
BD Micro-Fine TM + Pen
M/s Becton Dickinson administration
Needle 0.25MM (31G) *
Medical (S) PTE Ltd., 30 of a drug.
5MM
TUAS Avenue 2,
Singapore

(FSC Singapore Valid Till

23-01-2019)

(FSC Ireland Valid Till

23-11-2022)
Fee Submitted
Rs.25,000/-
193. M/s Ghazali Manufacturer: SpineLP Disposable Anaesthesia Approved
Brothers, 1st M/s Zhejiang Kindly Anaesthesia Needles (Spinal subject to
Floor, Azzainab Medical Devices Co., Needle) foreign
Court Compbell Ltd., No.758, 5th Binhai Class D inspection
Street, Karachi Road Binhai Industrial abroad. The
Shelf Life: 5 Years
Park, Longwan District Board also
(ELI-00240) 325025 Wenzhou, authorized
27G (0.4), 26G (0.45),
Evaluator: Zhejiang Province, P.R the Secretary
25G (0.5), 24G (0.55),
Muhammad China MDB to issue
23G (0.6), 22G (0.7), 21G
Ayub Naveed registration
(0.8), 20G (0.9), 19G
(FSC China Valid Till of product if
(1.1), 18G (1.2), 17G
25-05-2019) the
(1.4), 16G (1.6), 15G
manufacturin
(1.8), 14G (2.1)
Fee Submitted g plant is
Rs.50,000/- approved by
the panel of
experts.

194. -do- Market By: Supercath 5 I.V Catheter Approved.

152
 M/s Togo Medikit Co., (Safety)
Evaluator: Ltd., 13-2, Yushima, 1 Class B
Muhammad Chome, Bunkyo-ku,
Shelf Life: 5 Years
Ayub Naveed Tokyo, 113-0034, Japan
SP125-14-31T, SP125-
Manufacturing Site:
16-31T, SP125-24-19T,
M/s Togo Medikit Co.,
SP125-18-31T, SP125-
Ltd., Hyuga Factory
20-31T, SP125-22-31T,
17148-6, Aza Kamekawa,
SP125-22-25T, SP125-
Oaza Hichiya, Hyuga
24-19T, SP125-14-31WT,
City, Miyazaki
SP125-16-31WT,
Prefecture 883-0062,
SP125-24-19WT,
Japan
SP125-18-31WT,
SP125-20-31WT,
(FSC Japan Issuance
SP125-22-31WT,
Date 30-11-2018)
SP125-22-25WT,
SP125-24-19WT
Rs.100,000/-
Fee Already Submitted
against Slip No. 0069284
dated 16-12-15

195. M/s Sure Bio- Owner Operator/ AccuDiag TM Total In- vitro Approved.
Diagnostics& Manufacturer: Human IgE ELISA Kit diagnostic test
Pharmaceuticals, M/s Diagnostic kit for
EE-10, Defense Automation / Cortez Class B qualitative
View Phase-II, Diagnostics Inc., 21250 analysis of anti
Shelf Life: 12 Months
Near Iqra Califa St, Suite 102 and IgE antibodies
University 116 Woodland Hills, CA based on solid
Shaheed-e-Millat 91367, USA phase enzyme
Express Way, linked
Karachi immunosorbe
(FSC USFDA Valid Till nt assay.
(ELI-00084) 29-07-2020)
Fee Submitted
Evaluator: Rs.25,000/-
Muhammad
Ayub Naveed
196. M/s Shirazi Manufacturer: X-Ray System, Stationary Approved
Trading M/s Ge Hualun Medical Diagnostic, General Basic subject to
Company (Pvt) Systems Co., Ltd., No 1, Purpose, Fixed, Digital Diagnostic X- foreign
Ltd., 114-C, Al- Yong Chang North Brivo XR 575 Ray System inspection
Murtaza Road, Beijing Economic Digital abroad. The
Commercial Technological Class C Board also
Lane 3, Off Development Zone authorized
Khayaban-e- 100176 Beijing, China Shelf Life: N/A the Secretary
Iqbal, Khayaban- MDB to issue
e-Shaheen, DHA (FSC China Valid Till registration
Phase 8, Karachi 30-05-2020) of product if
Fee Submitted the
(ELI-00263) Rs.50,000/- manufacturin
153
 g plant is
Evaluator: approved by
Muhammad the panel of
Ayub Naveed experts.

197. -do- Manufacturer: Revlolution EVO X-Ray System, Approved.

M/s GE Healthcare Diagnostic,
Evaluator: Japan Corportion 7-127, Class C Computed
Muhammad Asahigaoka 4-Chome, Tomography,
Ayub Naveed Hino-Shi, Tokyo 191- Shelf Life: N/A Full Body
8503, Japan
226ACBZX00037000
(FSC Japan Issuance
Date 07-04-2016)

Fee Submitted
Rs.50,000/-

198. -do- Manufacturer: Anesthesia Machine Anesthesia Approved

M/s GE Medical 9100c NXT System subject to
Evaluator: Systems (China) Co., foreign
Muhammad Ltd., No. 19, Changjiang Class C inspection
Ayub Naveed Road, No.22 GaoLang abroad. The
Esat Road, Wuxi Shelf Life: N/A Board also
National Hi-Tech Dev. authorized
Zone, 214028 Jiangsu, the Secretary
China MDB to issue
registration
(FSC China Valid Till of product if
09-01-2020) the
manufacturin
Fee Submitted g plant is
Rs.50,000/- approved by
the panel of
experts.

199. -do- Manufacturer: System, Tomography, Emission Approved.

M/s GE Medical Computed, Emission Computed
Evaluator: Systems, LLC 3000 N Discovery IQ Tomography
Muhammad Grandview Blvd. System
Ayub Naveed Waukesha, WI 53188, Class C
USA
Shelf Life: N/A
(FSC USFDA Valid Till
09-04-2020)
Fee Submitted
Rs.50,000/-
200. -do- Manufacturer: Computed X Ray System, Approved
M/s GE Hangwei Tomography System Diagnostic, subject to
Evaluator: Medical Systems Co., Optima CT520 Computed foreign
Muhammad Ltd., West Area of Tomography, inspection
154
 Ayub Naveed Building No.3, No.1 Class C Full Body abroad. The
Yongchang North Road, Board also
Beijing Economic and Shelf Life: N/A authorized
Technological the Secretary
Development Area, MDB to issue
Beijing 100176, China registration
(FSC China Valid Till of product if
03-07-2019) the
manufacturin
Fee Submitted g plant is
Rs.50,000/- approved by
the panel of
experts.

201. -do- Manufacturer: Anesthesia Machine Anesthesia Approved

M/s GE Medical (Carestation 30) Workstation, subject to
Evaluator: Systems (China) Co., General foreign
Muhammad Ltd., No. 19, Changjiang Class C Purpose inspection
Ayub Naveed Road Wuxi National Hi- abroad. The
Tech Dev. Zone, 214028 Shelf Life: 10 Years Board also
Jiangsu, China authorized
the Secretary
(FSC China Valid Till MDB to issue
26-09-2020) registration
of product if
Fee Submitted the
Rs.50,000/- manufacturin
g plant is
approved by
the panel of
experts.

202. -do- Manufacturer: Computed X Ray System, Approved

M/s GE Hangwei Tomography System Diagnostic, subject to
Evaluator: Medical Systems Co., (Revolution ACT) Computed foreign
Muhammad Ltd., West Area of Tomography, inspection
Ayub Naveed Building No.3, No.1 Class C Full Body abroad. The
Yongchang North Road, Board also
Beijing Economic and Shelf Life: N/A authorized
Technological the Secretary
Development Area, MDB to issue
Beijing 100176, China registration
of product if
(FSC China Valid Till the
14-05-2019) manufacturin
Fee Submitted g plant is
Rs.50,000/- approved by
the panel of
experts.

203. -do- Manufacturer: Computed X Ray System, Approved

M/s GE Hangwei Tomography System Diagnostic, subject to
155
 Evaluator: Medical Systems Co., (Optima CT540) Computed foreign
Muhammad Ltd., West Area of Tomography, inspection
Ayub Naveed Building No.3, No.1 Class C Full Body abroad. The
Yongchang North Road, Board also
Beijing Economic and Shelf Life: N/A authorized
Technological the Secretary
Development Area, MDB to issue
Beijing 100176, China registration
of product if
(FSC China Valid Till the
11-01-2020) manufacturin
Fee Submitted g plant is
Rs.50,000/- approved by
the panel of
experts.

204. -do- Manufacturer: Gas-Machine, Anesthesia Approved.

M/s Datex-Ohmeda, Anesthesia (Aisys CS2) Workstation,
Evaluator: Inc., 3030 Ohmeda Drive General-
Muhammad Madison, WI 53718, USA Class C Purpose
Ayub Naveed
(FSC USFDA Valid Till Shelf Life: N/A
08-10-2020)
Fee Submitted
Rs.50,000/-

205. -do- Manufacturer: Patient Monitor ( B 40) Single-Patient Approved

M/s GE Medical Physiologic subject to
Evaluator: Systems (China) Co., Class C Monitoring foreign
Muhammad Ltd., No. 19, Changjiang System inspection
Ayub Naveed Road, No.22 GaoLang Shelf Life: N/A abroad. The
Esat Road, Wuxi Board also
National Hi-Tech Dev. authorized
Zone, 214028 Jiangsu, the Secretary
China MDB to issue
registration
(FSC China Valid Till of product if
29-01-2020) the
Fee Submitted manufacturin
Rs.50,000/- g plant is
approved by
the panel of
experts.

206. -do- Manufacturer: Patient Monitor (B 20) Single-Patient Approved

M/s GE Medical Physiologic subject to
Evaluator: Systems (China) Co., Class C Monitoring foreign
Muhammad Ltd., No. 19, Changjiang System inspection
Ayub Naveed Road, No.22 GaoLang Shelf Life: N/A abroad. The
Esat Road, Wuxi Board also
National Hi-Tech Dev. authorized
Zone, 214028 Jiangsu, the Secretary
156
 China MDB to issue
registration
(FSC China Valid Till of product if
29-01-2020) the
manufacturin
Fee Submitted g plant is
Rs.50,000/- approved by
the panel of
experts.

207. -do- Legal Manufactuer: System, X-Ray, X-Ray System, Approved.

M/s GE Medical Tomography, Diagnostic,
Evaluator: Systems, LLC 3000N Computed (Revolution Computed
Muhammad Grandview BLVD. Frontier) Tomography,
Ayub Naveed Waukesha, WI 53188, Full-Body
USA Class C

Manufacturer: Shelf Life: N/A

M/s GE Hangwei
Medical Systems Co.,
Ltd., West Area of
Building No.3, No.1
Yongchang North Road,
Beijing Economic and
Technological
Development Area,
Beijing 100176, China

(FSC USFDA Valid Till

07-11-2020)
Fee Submitted
Rs.50,000/-

208. M/s Sorabjee Manufacture: Fractionated Silicon oil Fractionated Approved.

Patel& Co., 45 M/s Arcadophta Sarl 11, for Ophthalmic use Silicone Oil
Badri Building I.I Rue Antoine Ricord ARCIOLANE 1300 and
Chundrigar 31100 Toulouse, France ARCIOLANE 5500
Road, Karachi
(FSC France Issuance Class C
(ELI-00067) Date
13-01-2016) Shelf Life: 3 Years

209. -do- Manufacture: RayOne Toric Hydrophilic Approved.

M/s Rayner Intraocular (RAO610T) Flodable IOL
Evaluator: Lenses Limited, The
Muhammad Ridley Innovation Class C
Ayub Naveed Centre, 10 Dominion
Way, Worthing, West Shelf Life: 5 Years
157
 Sussex, BN14 8AQ, UK

(FSC UK Issuance Date

04-06-2018)

Fee Submitted
Rs.50,000/-

210. -do- Manufacture: RayOne Trifocal Hydrophilic Approved.

M/s Rayner Intraocular (RAO603F) Flodable IOL
Evaluator: Lenses Limited, The
Muhammad Ridley Innovation Class C
Ayub Naveed Centre, 10 Dominion
Way, Worthing, West Shelf Life: 5 Years
Sussex, BN14 8AQ, UK

(FSC UK Issuance Date

04-06-2018)

Fee Submitted
Rs.50,000/-

211. -do- Manufacture: Gas for Ophthalmic SF6: Sulfur Approved.

M/s Arcadophta Sarl 11, Surgery Arceole Single Hexafluoride
Evaluator: Rue Antoine Ricord Dose SF6, Arceole C2F6:
Muhammad 31100 Toulouse, France Single Dose C2f6, Hexafluoroeth
Ayub Naveed Arceole Single Dose ane
(FSC France Issuance C3F8 C3F8:
Date Octafluoropro
13-01-2016) Class C pane

Fee Submitted Shelf Life: 3 Years

Rs.50,000/-

212. -do- Manufacture: Methylvisc 2.0% (R- Hydroxy Approved.

M/s Rayner Intraocular MLV20) Propylmethyl
Evaluator: Lenses Limited, The Cellulose
Muhammad Ridley Innovation Class C
Ayub Naveed Centre, 10 Dominion
Way, Worthing, West Shelf Life: 3 Years
Sussex, BN14 8AQ, UK

(FSC UK Issuance Date

04-01-2018)
Fee Submitted
Rs.50,000/-

213. -do- Manufacture: RayOne Spheric Hydrophilic Approved.

M/s Rayner Intraocular (RAO100C) Flodable IOL
Evaluator: Lenses Limited, The
Muhammad Ridley Innovation Class C
Ayub Naveed Centre, 10 Dominion
158
 Way, Worthing, West Shelf Life: 5 Years
Sussex, BN14 8AQ, UK

(FSC UK Issuance Date

04-06-2018)
Fee Submitted
Rs.50,000/-

214. -do- Manufacture: Liquid These gases Approved.

M/s Arcadophta Sarl 11, Porfluorocatbone for are used in the
Evaluator: Rue Antoine Ricord Ophthalmic use retinal
Muhammad 31100 Toulouse, France ARCALINE/ARCOTA detachment of
Ayub Naveed NE the eye
(FSC France Issuance
Date Class C
13-01-2016)
Shelf Life: 3 Years
Fee Submitted
Rs.50,000/-

215. -do- Manufacture: RayOne Hydrophobic Hydrophilic Approved.

M/s Rayner Intraocular Aspheric (RAO800C) Flodable IOL
Evaluator: Lenses Limited, The
Muhammad Ridley Innovation Class C
Ayub Naveed Centre, 10 Dominion
Way, Worthing, West Shelf Life: 5 Years
Sussex, BN14 8AQ, UK

(FSC UK Issuance Date

04-06-2018)

Fee Submitted
Rs.50,000/-

216. -do- Manufacture: OphteisBio 1.8% (R- Viscoelastic Approved.

M/s Rayner Intraocular OPB18) Solution for
Evaluator: Lenses Limited, The intraocular use
Muhammad Ridley Innovation Class C
Ayub Naveed Centre, 10 Dominion
Way, Worthing, West Shelf Life: 5 Years
Sussex, BN14 8AQ, UK

(FSC UK Issuance Date

04-01-2018)
Fee Submitted
Rs.50,000/-

217. -do- Manufacture: RayOne Aspheric Hydrophilic Approved.

M/s Rayner Intraocular (RAO600C) Foldable IOL
Evaluator: Lenses Limited, The
Muhammad Ridley Innovation Class C
Ayub Naveed Centre, 10 Dominion
159
 Way, Worthing, West Shelf Life: 5 Years
Sussex, BN14 8AQ, UK

(FSC UK Issuance Date

04-06-2018)
Fee Submitted
Rs.50,000/-

218. M/s. Progressive M/s. Suzhou Junkang High Flux The Approved
Corporation, Medical Technology Co., Hemodialyzer, Hollow Hemodialyzer subject to
147-D, Ltd, Fiber Hemodialyzer adaptively be Embassy
Commercial No.28 Wutaishan Road, used for attested FSC.
Broadway, SND, Suzhou, Jiangsu, LoF10, L0F12, LoF14, hemodialysis
Phase-8 DHA, China. LoF16, LoF18, LoF20 in chronic or
Lahore. acute renal
FSC China Valid till 11- Class B failure
(ELI-00114) 07-2020 Shelf Life : 03 years patients.
FSC Germany
Evaluator: Issued on 17-01-2018
Muhammad
Ayub Naveed Fee Submitted
Rs. 25,000

219. M/s Bio Medics Manufacturer: Diacart (Bicarbonate Sodium Approved.

Medical System, M/s Serumwerk Cartidge for Bicarbonate
F-597, F-Block, Bernburg Vertriebs Haemodialysis) Cartidge for
Satellite Town, GmbH Hallesche Haemodialysis
Rawalpindi Landstrabe 105 b 06406 Class C
Bernburg, Germany
Shelf Life: 36 Months
(ELI-00022)
650g, 720g, 750g, 760g,
Evaluator: (FSC Germany Issuance 1100g
Unum Zia Date
Shamsi 19-10-2018)

Fee: Rs.50,000/-
220. -do- Manufacturer ECO Microwave The system Approved.
(i) M/s. Nanjing ECO Therapeutic System consists of
Evaluator: Microwave System (Microwave microwave
Muhammad Co., Ltd., 3rd& 4th Therapeutic System) source,
Ayub Naveed Floors, J5 Building microwave
NJUT Science ECO-100A2 radiator,
Industrial Park No. ECO-100E2 control system,
15, Wanshou Road, ECO-100E display system
Pukou District, ECO-100D1 and
211800 Nanjing, ECO-100D temperature
China. ECO-100D2 measurement
(ii) M/s. Easter Vargas system. A
Pizarro, Traductora Class C mamimum of
e Interprete Jurada Shelf Life : N.A 2 microwave
160
 Ingles, Poligono sources can be
Industrial Las configured for
Salinas each product.
C/o. Manantial, 13 –
Oficina 103, Edificio
CEEI, 11500 EI
Puerto de Santa
Maria, Spain

FSC Spain
Issued on 9th June, 2017
Fee Rs. 50,000

221. -do- Manufacturer ECO Disposable This product Approved.

M/s. Nanjing ECO Microwave consists of
Evaluator: Microwave System Co., (Microwave disposable
Muhammad Ltd., 3rd& 4th Floors, J5 Therapeutic System) microwave
Ayub Naveed Building NJUT Science antenna and
Industrial Park No. 15, ECO-100AI1, cooling
Wanshou Road, Pukou ECO-100AI20C, circulation
District, 211800 Nanjing, ECO-100AI21C, system.
China. ECO-100Al22, Dispoable
ECO-100AI5C, microwave
(i) M/s. Easter Vargas ECO-100AL5C, antenna
Pizarro, Traductora e ECO-100AL22C, consists of
Interprete Jurada ECO-100CL5C, radiator,
Ingles, Poligono ECO- 100CL22C, handle,
Industrial Las Salinas ECO-100A113C, microwave
C/o. Manantial, 13 – ECO-100AL13C, cable and
Oficina 103, Edificio ECO-100A1123C cooling
CEEI, 11500 EI Puerto ECO-100AL23C, medium pipe.
de Santa Maria, Spain ECO- 100AI8C,
ECO- 100AL81C,
FSC Spain ECO- 100A1110C,
Issued on 9th June, 2017 ECO-100AL10C,
ECO-MAU 1C,
Fee Rs. 50,000 ECO- 100AL81C,
ECO-100CL8,
ECO-100CL10,
ECO- 100CL11,
ECO- 100CL8C,
ECO-100CL10C,
ECO-100CL11C,
ECO-100AI25,
ECO-100F-2522,
ECO-100F-1210,

Class C
Shelf Life : N.A

161
222. -do- Manufacturer: DiaCart Sodium Rejected.
M/s Serumwerk Bicarbonate Cartridge Bicarbonate The product
Evaluator: Bernburg Vertriebs for Haemodialysis Cartridge for has already
Muhammad GmbH Hallesche Haemodialysis been
Ayub Naveed Landstrabe 105 b 06406 Class C registered at
Bernburg, Germany serial no. 219.
Shelf Life: 36 Months
(Duplication)
650g, 720g, 750g, 760g,
(FSC Germany Issuance 1100g
Date
19-10-2018) Fee submitted:
Rs.50,000/-

223. M/s B.Braun Manufacturer: SeQuent NEO NC Non- Approved.

Pakistan (Pvt) M/s B. Braun Melsungen Compliant
Ltd., AG Carl-Braun-Strabe 1 Class D PTCA Balloon
The Forum, Suite 34212 Melsungen, Catheter
Shelf Life: 3 Years
216, Khayaban-e- Germany
Jami, Block 9,
5023900 SEQUENT
Clifton, Karachi Manufacturing Site:
NEO NC 2.0 X 8 MM
M/s Natec Medical Ltd.,
(ELI-00006) Maeva Centre Building,
5023901 SEQUENT
Silicon Avenue, Ebene
NEO NC 2.25 X 8 MM
Evaluator: Business Park, Reduit
Unum Zia 72201, Mauritius
5023902 SEQUENT
Shamsi
NEO NC 2.5 X 8 MM
(FSC Germany Issuance
Date
5023903SEQUENT
29-11-2018)
NEO NC 2.75 X 8 MM

5023904
Fee submitted:
SEQUENT NEO
Rs.50,000/-
NC 3.0 X 8 MM

5023905 SEQUENT
NEO NC 3.25 X 8 MM

5023906
SEQUENT NEO
NC 3.5 X 8 MM

5023907
SEQUENT NEO
NC 4.0 X 8 MM

5023908
SEQUENT NEO
NC 4.5 X 8 MM

5023910
SEQUENT NEO

162
NC 2.0 X 10 MM

5023911
SEQUENT NEO
NC 2.25 X 10 MM

5023912
SEQUENT NEO
NC 2.5 X 10 MM

5023913
SEQUENT NEO
NC 2.75 X 10 MM

5023914
SEQUENT NEO
NC 3.0 X 10 MM

5023915
SEQUENT NEO
NC 3.25 X 10 MM

5023916
SEQUENT NEO
NC 3.5 X 10 MM

5023917
SEQUENT NEO
NC 4.0 X 10 MM

5023918
SEQUENT NEO
NC 4.5 X 10 MM

5023920
SEQUENT NEO
NC 2.0 X 12 MM

5023921
SEQUENT NEO
NC 2.25 X 12 MM

5023922
SEQUENT NEO
NC 2.5 X 12 MM

5023923
SEQUENT NEO
NC 2.75 X 12 MM

5023924
SEQUENT NEO
163
NC 3.0 X 12 MM

5023925
SEQUENT NEO
NC 3.25 X 12 MM

5023926
SEQUENT NEO
NC 3.5 X 12 MM

5023927
SEQUENT NEO
NC 4.0 X 12 MM

5023928
SEQUENT NEO
NC 4.5 X 12 MM

5023930
SEQUENT NEO
NC 2.0 X 15 MM

5023931
SEQUENT NEO
NC 2.25 X 15 MM

5023932
SEQUENT NEO
NC 2.5 X 15 MM

5023933
SEQUENT NEO
NC 2.75 X 15 MM

5023934
SEQUENT NEO
NC 3.0 X 15 MM

5023935
SEQUENT NEO
NC 3.25 X 15 MM

5023936
SEQUENT NEO
NC 3.5 X 15 MM

5023937
SEQUENT NEO
NC 4.0 X 15 MM

5023938
SEQUENT NEO
164
NC 4.5 X 15 MM

5023940
SEQUENT NEO
NC 2.0 X 20 MM

5023941
SEQUENT NEO
NC 2.25 X 20 MM

5023942
SEQUENT NEO
NC 2.5 X 20 MM

5023943
SEQUENT NEO
NC 2.75 X 20 MM

5023944
SEQUENT NEO
NC 3.0 X 20 MM

5023945
SEQUENT NEO
NC 3.25 X 20 MM

5023946
SEQUENT NEO
NC 3.5 X 20 MM

5023947
SEQUENT NEO
NC 4.0 X 20 MM

5023948
SEQUENT NEO
NC 4.5 X 20 MM

5023960
SEQUENT NEO
NC 2.0 X 30 MM

5023961
SEQUENT NEO
NC 2.25 X 30 MM

5023962
SEQUENT NEO
NC 2.5 X 30 MM

5023963
SEQUENT NEO
165
 NC 2.75 X 30 MM

5023964
SEQUENT NEO
NC 3.0 X 30 MM

5023965
SEQUENT NEO
NC 3.25 X 30 MM

5023966
SEQUENT NEO
NC 3.5 X 30 MM

5023967
SEQUENT NEO
NC 4.0 X 30 MM

5023968
SEQUENT NEO
NC 4.5 X 30 MM
224. -do- Manufacturer: Spinocan® (Needle for Spinal Needle Approved.
M/s B. Braun Melsungen Spinal Anaesthesia) for Spinal and
Evaluator: AG Carl-Braun-Strabe 1 Diagnostic
Hafiz 34212 Melsungen, Class D Puncture
Muhammad Asif Germany
Shelf Life: 5 Years
Iqbal
Manufacturing Site:
4501144, 4501195,
M/s Braun Medical
4501373, 4501900,
Industries Sdn. Bhd.,
4501918, 4502140,
Bayan Lepas Free
4502906, 4503902,
Industrial Zone 11900
4505751, 4505905,
Penang, Malaysia
4506014, 4507401,
4507754, 4507908,
(FSC Germany Issuance
4509757, 4509900,
Date
4504917, 4505913,
10-01-2019)
4506090
Fee Submitted
Rs.50,000/-

225. -do- Manufacturer: Pencan® (Needles for Spinal Needle Approved.

M/s B. Braun Melsungen Spinal Anaesthesia) for spinal and
Evaluator: AG Carl-Braun-Strabe 1 Class D Diagnostic
Hafiz 34212 Melsungen, Puncture
Shelf Life: 5 Years
Muhammad Asif Germany
Iqbal
4502043, 4502051,
Manufacturing Site:
4502116, 4502124
M/s Braun Medical
Industries Sdn. Bhd.,
Bayan Lepas Free
Industrial Zone 11900
166
 Penang, Malaysia

(FSC Germany Issuance

Date 10-01-2019)

Fee Submitted
Rs.50,000/-

226. M/s Otsuka Legal Manufacturer: Otsuka Infrared Analyzer Approved.

Pakistan M/s Otsuka Electronics Spectrophotometer designed for Shelf life is
Limited, 30-B, Co., Ltd., 3-26-3, Shodai- POCone on-site not
SMCHS, Karachi Tajika, Hirakata, Osaka, Option: POC-AS10 performance applicable.
573-1132, Japan of the 13C-urea
(ELI-00243) breath test for
Manufacturing Site: Class B detection of
Evaluator: M/s Otsuka Electronics H.Pylori
Unum Zia Co., Ltd., Shiga Plant 1- Shelf Life: not infection
Shamsi 10, Sasagaoka, applicable
Minakuchi, Koka, Shiga,
528-0061, Japan Fee submitted: Rs.
50,000/-
(FSC Japan Issue Date
07-12-2018)

227. M/s Anwar & Manufacturer: Cutanplast® Sterile, Approved.

Sons, Apartment M/s Mascia Brunelli Haemostat
No.10, Safari S.p.A., Viale Monza 272 Class D Gelatin
Villas-2, – 20128 Milano, Italy Sponge
Commercial Shelf Life: 05 Years
Complex, Phase- (FSC Italy Issuance Date
7, Bahria Town 03-03-2017) Cutanplast Standard
Rawalpindi Ref : 05170502
Fee submitted: 70x50x10mm (20 Pcs)
(ELI-00017) Rs.50,000/-
Cutanplast Special
Evaluator: Ref : 05380502
Unum Zia 70x50x1mm
Shamsi (20 Pcs)

Cutanplast Anal
Ref :05480302 80x30
Ǿmm
(20 Pcs)

Cutanplast Dental
Ref: 05610101 10x10x10
mm
(24 Pcs)

Cutanplast Film
Ref: 05770202
200x70x0.5mm (20 Pcs)
167
 Cutanplast Dial
Ref: 05230302
30x30x10mm
(20 Pcs)

Cutanplast
Ref: 05520602 20x60x7
mm
(20 Pcs)

Cutanplast Large
Ref: 058801251
80x125x10mm (10 Pcs)

Cutanplast Small
Ref: 05850302
50x30x10mm
(20 Pcs)

228. -do- Manufacturer: Emosist ® Oxidized Approved.

M/s Mascia Brunelli Regenerated
Evaluator: S.p.A., Viale Monza 272 1. Ref :06125513 Cellulose
Unum Zia – 20128 Milano, Italy Size 1.25x5 cm (10pcs)
Shamsi
(FSC Italy Issuance Date 2.Ref :06755013 Size 7.5
03-03-2017) x5 cm (10pcs)

3. Ref :06201013
Size 10x20 cm (10pcs)
4. Ref :06355013 Size 35
x 5 c(10 pcs)

Class D

Shelf Life : 03 years

Fee submitted:
Rs.50,000/-

229. M/s Krestacorp, Legal Manufacturer/ Klear Rapid Self Approved

76-C, 3rd Floor, Manufacturing Site: Human Chorionic Pregnancy subject to
Suit No.2, M/s Jei Daniel Biotech Gonadotropin (HCG) Test Strip foreign
Khayaban-e- Corp., Jinan Facility, Rapid Test Kit inspection
Jami, Street No.9, A201, 1st Building No69, (Colloidal Gold) abroad. The
DHA Phase 7, Hua Yang Road Jinan, Board also
Karachi ShangDong, China. Class B authorized
the Secretary
(ELI-00258) (FSC China Valid Till Shelf Life: 3 Years MDB to issue
10-05-2020) registration
Evaluator: Fee submitted: of product if
Unum Zia Rs.50,000/- the
168
 Shamsi manufacturin
g plant is
approved by
the panel of
experts.
Only one
brand shall
be given.
230. -do- Legal Manufacturer/ OneTest Rapid Self Product is
Manufacturing Site: Human Chorionic Pregnancy similiar at
Evaluator: M/s Jei Daniel Biotech Gonadotropin (HCG) Test Strip serial no. 229.
Unum Zia Corp., Jinan Facility, Rapid Test Kit only brand is
Shamsi A201, 1st Building No69, (Colloidal Gold) change.
Hua Yang Road Jinan, therefore,
ShangDong, China. Class B Already
considered at
(FSC China Valid Till Shelf Life: 3 Years serial no. 229.
10-05-2020)
Fee submitted:
Rs.50,000/-

231. M/s Trans Angio Manufacturer: Yukon Chrome PC Sirolimus Approved.

System, 507, M/s Translumina GmbH Eluting CoCr
Progressive Neue Rottenburger Class D Coronary Stent
Square, Block-6, Strabe 50, 72379 System
PECHS, Hechingen, Germany Shelf Life: 18 Months
Shahrah-e-Faisal,
Karachi (FSC Germany Issuance T-CMG2008PC, T-
Date 24-10-2017) CMG2012PC, T-
(ELI-00172) CMG2016PC, T-
Fee submitted Rs CMG2018PC, T-
Evaluator: 50,000/- CMG2021PC, T-
Unum Zia CMG2024PC, T-
Shamsi CMG2028PC, T-
CMG2032PC, T-
CMG2508PC, T-
CMG2512PC, T-
CMG2516PC, T-
CMG2518PC, T-
CMG2521PC, T-
CMG2524PC, T-
CMG2528PC T-
CMG2532PC, T-
CMG27508PC, T-
CMG27512PC, T-
CMG27516PC, T-
CMG27518PC, T-
CMG27521PC, T-
CMG27524PC, T-
CMG27528PC, T-
CMG27532PC, T-
CMG27540PC, T-
169
 CMG3008PC, T-
CMG3012PC, T-
CMG3016PC, T-
CMG3018PC, T-
CMG3021PC, T-
CMG3024PC, T-
CMG3028PC, T-
CMG3032PC, T-
CMG3040PC, T-
CMG3508PC, T-
CMG3512PC, T-
CMG3516PC, T-
CMG3518PC, T-
CMG3521PC, T-
CMG3524PC, T-
CMG3528PC, T-
CMG3532PC, T-
CMG3540PC,
T-CMG4008PC, T-
CMG4012PC, T-
CMG4016PC, T-
CMG4018PC, T-
CMG4021PC, T-
CMG4024PC, T-
CMG4028PC, T-
CMG4032PC, T-
CMG4040PC

232. M/s Royal Manufacturer: Folee Portable Phlegm For sucking Approved.
Enterprises, M/s Jiangsu Folee Suction Unit thick liquid Shelf life not
Shop No. 5, Medical Equipment Co., such as pus- applicable.
Karimji Building, Ltd. Class B blood and
Opp HBL North No. 16, Xingmao Road, phelgm under
Napier Road, Zhenjiang City, China Shelf Life: Not negative
Karachi applicable pressure
(FSC China Valid Till
(ELI-00062)
31-08-2019) H003-A, H003-B, H003-
Evaluator: Fee submitted: C
Unum Zia Rs.25,000/-
Shamsi
233. -do- Manufacturer: Folee Bedsore Bedsore Approved
M/s Jiangsu Folee Prevention Mattress Prevention subject to
Evaluator: Medical Equipment Co., Mattress foreign
Unum Zia Ltd. Class B inspection
Shamsi No. 16, Xingmao Road, abroad. The
Zhenjiang City, China Shelf Life: Not Board also
applicable authorized
(FSC China Valid Till the Secretary
31-08-2019) J001, J001-A, J002, J003, MDB to issue
J003-A J006, J009-A registration
of product if
Fee submitted: the
170
 Rs.25,000/- manufacturin
g plant is
approved by
the panel of
experts.
Shelf life not
applicable.
234. -do- Manufacture: Folee Oxygen Used to Approved
M/s Jiangsu Folee Concentrator ( Model: generate subject to
Evaluator: Medical Equipment Co., Y007-1) oxygen for the foreign
Unum Zia Ltd., No. 16, Xingmao oxygen- inspection
Shamsi Road, Zhenjiang City, Class B deficient abroad. The
China patients Board also
Shelf Life: Not authorized
(FSC China Valid Till applicable the Secretary
31-08-2019) MDB to issue
Fee Submitted: Rs. registration
25,000/- of product if
the
manufacturin
g plant is
approved by
the panel of
experts.
Shelf life not
applicable.
235. M/s Matrix Manufacturer: Bonisa® Bone Recombinant Approved
Pharma (Pvt) M/s Hangzhou Jiuyuan Repairing Material (0.5 Human Bone subject to
Ltd., Plot No. 12, Gene Engineering Co., mg rhBMP-2/vial) Morphogeneti foreign
Sector 15, Ltd., No. 23, No.8th c Protein-2 inspection
Korangi Street, Hangzhou Econ. Class D (rhBMP-2) abroad. The
Industrial Area, & Tech. Development with Board also
Karachi Zone, China Shelf Life: 02 Years osteoinductive authorized
Manufacturing site: bioactivity, the Secretary
(ELI-00039) No. 866, Moganshan Fee Submitted: Rs indicated for MDB to issue
Road (No. 700, Shixiang 50,000/- use in bone registration
Evaluator: Road), Hangzhou, China defect, bone of product if
Unum Zia (FSC China Valid Till nonunion, the
Shamsi 17-09-2020) bone delayed manufacturin
union or g plant is
nonunion approved by
resulted from the panel of
various causes, experts.
spinal fusion
joint fusion The Board
and referred the
orthopaedic product for
implantation expert
opinion from
Dr. Khalid S.
Aslam,
whether the
171
 product is
required in
orthopaedic
surgery and
how effective
it is?
236. -do- Manufacturer: Bonisa® Bone Recombinant Approved
M/s Hangzhou Jiuyuan Repairing Material (2.0 Human Bone subject to
Evaluator: Gene Engineering Co., mg rhBMP-2/vial) Morphogeneti foreign
Unum Zia Ltd., No. 23, No.8th c Protein-2 inspection
Shamsi Street, Hangzhou Econ. Class D (rhBMP-2) abroad. The
& Tech. Development with Board also
Zone, China Shelf Life: 02 Years osteoinductive authorized
Manufacturing site: bioactivity, the Secretary
No. 866, Moganshan Fee Submitted: Rs indicated for MDB to issue
Road (No. 700, Shixiang 50,000/- use in bone registration
Road), Hangzhou, China defect, bone of product if
(FSC China Valid Till nonunion, the
17-09-2020) bone delayed manufacturin
union or non- g plant is
union resulted approved by
from various the panel of
causes, spinal experts.
fusion joint
fusion and The Board
orthopaedic referred the
implantation product for
expert
opinion from
Dr. Khalid S.
Aslam,
whether the
product is
required in
orthopaedic
surgery and
how effective
it is?
237. -do- Manufacturer: Bonisa® Bone Recombinant Approved
M/s Hangzhou Jiuyuan Repairing Material (1.0 Human Bone subject to
Evaluator: Gene Engineering Co., mg rhBMP-2/vial) Morphogeneti foreign
Unum Zia Ltd., No. 23, No.8th c Protein-2 inspection
Shamsi Street, Hangzhou Econ. Class D (rhBMP-2) abroad. The
& Tech. Development with Board also
Zone, China Shelf Life: 02 Years osteoinductive authorized
Manufacturing site: bioactivity, the Secretary
No. 866, Moganshan Fee Submitted: Rs indicated for MDB to issue
Road (No. 700, Shixiang 50,000/- use in bone registration
Road), Hangzhou, China defect, bone of product if
(FSC China Valid Till nonunion, the
17-09-2020) bone delayed manufacturin
union or non- g plant is
172
 union resulted approved by
from various the panel of
causes, spinal experts.
fusion joint
fusion and The Board
orthopaedic referred the
implantation product for
expert
opinion from
Dr. Khalid S.
Aslam,
whether the
product is
required in
orthopaedic
surgery and
how effective
it is?
238. M/s Ali Gohar & Legal Manufacturer: ACRYSOF® IQ Sterile, Approved
Company (Pvt) M/s Alcon Laboratories, PanOptixTM Toric ultraviolet and subject to
Ltd., State Life Inc. 6201 South Freeway Presbyopia-Correcting blue-light provision of
Building 1-B, I.I Fort Worth, Texas, USA IOL filtering, stability
Chundrigar 76134-2099 Acrylic studies data
Road, Karachi Manufacturing Site: Class C Foldable supporting 5
M/s Alcon Research, Single-Piece years shelf.
Shelf Life: 5 years
(ELI-00004) Ltd., Intraocular
6065 Kyle Lane Lens
Model: TFNT20,
Evaluator: Huntington, WV 25702,
TFNT30, TFNT40,
Unum Zia USA
TFNT50, TFNT60
Shamsi
(FSC Belgium Issue Date
Fee Submitted: Rs
15-10-2018)
50,000/-
FSC Australia Issue Date
23-08-2018)

239. -do- Legal Maufacturer: ACRYSOF® Single Sterile, UV Approved.

M/s Alcon Laboratories, Piece IOL absorbing,
Evaluator: Inc. 6201 South Freeway acrylic,
Unum Zia Fort Worth, Texas, USA Class C foldable,
Shamsi 76134-2099 single-piece
Shelf Life: 5 years.
Manufacturing Site: posterior
1) M/s Alcon Research, chamber
Model: SA60AT
Ltd., 6065 Kyle Lane Intraocular
Huntington, WV 25702, Lens
Fee Submitted: Rs
USA
50,000/-
2) M/s Alcon
Laboratories Ireland
Cork Business &
Technology Park, Model
Farm Road, Cork,
Ireland

173
 (FSC US FDA Valid Till
13-02-2020)
(FSC Ireland Valid Till
17-01-2023)
(FSC Australia Issue
Date
23-08-2018)

240. -do- Legal Maufacturer: ACRYSOF® IQ Sterile, UV and Approved.

M/s Alcon Laboratories, Aspheric Natural blue light
Evaluator: Inc. 6201 South Freeway Single-Piece Intraocular filtering,
Unum Zia Fort Worth, Texas, USA Lens acrylic,
Shamsi 76134-2099 foldable,
Manufacturing Site: Class C single-piece,
1) M/s Alcon Research, posterior
Shelf Life: 5 years
Ltd., 6065 Kyle Lane chamber
Huntington, WV 25702, Intraocular
SN60WF
USA Lens
2) M/s Alcon
Fee Submitted: Rs
Laboratories Ireland
50,000/-
Cork Business &
Technology Park Model
Farm Road, Cork Ireland

(FSC US FDA Valid Till

13-02-2020)
(FSC Ireland Valid Till
17-01-2023)
(FSC Australia Issue
Date
23-08-2018)

241. -do- Legal Maufacturer: ACRYSOF® IQ Sterile, UV and Approved.

M/s Alcon Laboratories, ReSTOR® Multifocal blue light
Evaluator: Inc. 6201 South Freeway Intraocular Lens filtering,
Unum Zia Fort Worth, Texas, USA foldable,
Shamsi 76134-2099 Class C single-piece,
Manufacturing Site: apodized,
Shelf Life: 5 years
1) M/s Alcon Research, diffractive,
Ltd., 6065 Kyle Lane aspheric,
SN6AD1
Huntington, WV 25702, posterior
USA chamber
Fee Submitted: Rs
2) M/s Alcon Intraocular
50,000/-
Laboratories Ireland Lens
Cork Business &
Technology Park Model
Farm Road, Cork Ireland

(FSC US FDA Valid Till

13-02-2020)
(FSC Ireland Valid Till
17-01-2023)
174
 (FSC Australia Issue
Date 23-08-2018)

242. -do- Legal Maufacturer: ACRYSOF® IQ Toric Sterile, UV and Approved.

M/s Alcon Laboratories, Astigmatism blue light
Evaluator: Inc. 6201 South Freeway Intraocular Lens filtering
Unum Zia Fort Worth, Texas, USA acrylic,
Shamsi 76134- foldable, toric,
Class C
2099Manufacturing Site: aspheric, optic,
1) M/s Alcon Research, single-piece
Ltd., 6065 Kyle Lane posterior
Shelf Life: 5 years
Huntington, WV 25702, chamber lens
USA
SN6AT2, SN6AT3,
2) M/s Alcon
SN6AT4, SN6AT5,
Laboratories Ireland
SN6AT6, SN6AT7,
Cork Business &
SN6AT8, SN6AT9
Technology Park Model
Farm Road, Cork Ireland
Fee Submitted: Rs
50,000/-
(FSC US FDA Valid Till
13-02-2020)
(FSC Ireland Valid Till
17-01-2023)
(FSC Belgium Issue Date
09-06-2017)

243. -do- Legal Maufacturer: ACRYSOF® IQ Sterile, UV and Approved

M/s Alcon Laboratories, Aspheric IOL with the blue light subject to
Evaluator: Inc. 6201 South Freeway UltraSert® Pre-Loaded filtering provision of
Unum Zia Fort Worth, Texas, USA Delivery System acrylic, stability
Shamsi 76134-2099 foldable, studies data
Manufacturing Site: Class C single-piece supporting 5
1) M/s Alcon Research, posterior years shelf.
Shelf Life: 5 years
Ltd., 6065 Kyle Lane chamber
Huntington, WV 25702, intraocular
AU00T0
USA lens with the
2) M/s Alcon UltraSert®
Fee Submitted: Rs
Laboratories Ireland, Pre-Loaded
50,000/-
Cork Business & Delivery
Technology Park Model System
Farm Road, Cork Ireland

(FSC US FDA Valid Till

13-02-2020)
(FSC Ireland Valid Till
17-01-2023)
(FSC Australia Issue
Date
23-08-2018)

244. -do- Legal Maufacturer: ACRYSOF® IQ Sterile, UV and Approved

M/s Alcon Laboratories, Aspheric blue light subject to
175
 Evaluator: Inc. 6201 South Freeway Natural IOL with filtering provision of
Unum Zia Fort Worth, Texas, USA Acrysert C Delivery acrylic, stability
Shamsi 76134-2099 System foldable, studies data
Manufacturing Site: single-piece supporting 5
M/s Alcon Research, Class C posterior years shelf.
Ltd., 6065 Kyle Lane chamber
Huntington, WV 25702, intraocular
Shelf Life: 5 years
USA lens with
Acrysert C
SN6CWS
(FSC US FDA Valid Till Delivery
13-02-2020) System
Fee Submitted: Rs
(FSC Australia Issue
50,000/-
Date
23-08-2018)

245. -do- Legal Maufacturer: ACRYSOF® Multi Sterile, UV Approved

M/s Alcon Laboratories, Piece IOL absorbing, subject to
Evaluator: Inc. 6201 South Freeway acrylic, provision of
Unum Zia Fort Worth, Texas, USA Class C foldable, stability
Shamsi 76134-2099 multi-piece studies data
Shelf Life: 5 years
Manufacturing Site: posterior supporting 5
M/s Alcon Research, chamber years shelf.
MA60AC, MA60MA
Ltd., 6065 Kyle Lane intraocular
Huntington, WV 25702, lens
Fee Submitted: Rs
USA
50,000/-
(FSC USFDA Valid Till
13-02-2020)
(FSC Australia Issue
Date
23-08-2018)
246. -do- Legal Maufacturer: ACRYSOF® IQ Sterile, UV and Approved
M/s Alcon Laboratories, RESTOR® Multifocal blue light subject to
Evaluator: Inc. 6201 South Freeway Toric IOL filtering, provision of
Unum Zia Fort Worth, Texas, USA acrylic, stability
Shamsi 76134-2099 Class C foldable, studies data
Manufacturing Site: apodized, supporting 5
Shelf Life: 5 years
M/s Alcon Research, diffractive, years shelf.
Ltd., 6065 Kyle Lane aspheric,
SND1T2, SND1T3,
Huntington, WV 25702, posterior
SND1T4, SND1T5,
USA chamber
SND1T6
intraocular
(FSC Belgium Issue Date lens
Fee Submitted: Rs
09-06-2017)
50,000/-
(FSC US FDA Valid Till
13-02-2020)
(FSC Australia Issue
Date
23-08-2018)
247. -do- Legal Maufacturer: ACRYSOF® IQ Sterile, UV and Approved
M/s Alcon Laboratories, PanOptixTM Presbyopia- blue light subject to
Evaluator: Inc. 6201 South Freeway Correcting IOL filtering, provision of
176
 Unum Zia Fort Worth, Texas, USA foldable, stability
Shamsi 76134-2099 Class C multi-focal studies data
Manufacturing Site: intraocular supporting 5
Shelf Life: 5 years
M/s Alcon Research, lens years shelf.
Ltd., 6065 Kyle Lane
TFNT00
Huntington, WV 25702,
USA
Fee Submitted: Rs
50,000/-
(FSC Belgium Issue Date
17-11-2017)
(FSC Australia Issue
Date
23-08-2018)
248. M/s IBL Legal Manufacturer: Bausch + Lomb ReNu Multipurpose Approved
Healthcare, 1st M/s Bausch & Lomb Multiplus Contact Lens subject to
Floor, N.I.C.L Incorporated, 1400 North Multipurpose Solution Care Solution provision of
Building Abbasi- Goodman Street, Essential
Shaheed Road, Rochester, NY 14609, Class C principles of
Karachi USA safety and
Shelf Life: 24 Months performance.
(ELI-00119) Manufacturing Site:
M/s Bausch & Lomb - Fee Rs 50,000/-
IOM S.p.A., Via Pasubio
Evaluator: 34, 20846 Macherio (MB),
Unum Zia Italy
Shamsi
(FSC Italy Issue Date
17-09-2018)

249. M/s Mars Manufacturer: Icare™ Nebulizer Approved

Enterprises, M/s Yiles Medical Co., Nebulizer Mask for mask for subject to
Office No.4, Ltd., Chuangye Road Single Use single use, foreign
Jason Centre, 2nd 1199, Jinxian, Nanchang sterile inspection
Floor, BC-8, City, 331700 Jiangxi, Class B abroad. The
Block No.9, China Board also
Clifton, Karachi Shelf Life: 05 Years authorized
(FSC China Valid Till the Secretary
(ELI-00097) 07-02-2020) Adult, Child (Pediatric) MDB to issue
registration
Evaluator: of product if
Unum Zia the
Shamsi manufacturin
g plant is
approved by
the panel of
experts.

Also subject
to provision
of Essential
177
 principles of
safety and
performance
and
Declaration
of
conformity.
250. M/s. Physiomed Legal Manufacturer/ Therapy ® Ablation Indicated for Approved.
(Pvt) Ltd, 268/3, Manufacturing Site Catheters use in the
Kamal Road treatment of
Saddar M/s. Irvine Biomedical Models AV nodal
Rawalpindi. Inc., a St. Jude Medical 83302 83306 reentrant
Company, 2375, Morse 83309 83351 tachycardia,
(ELI-00199) Avenue, Irvine CA, 83403 83404 for ablation of
92614, USA 83405 83408 accessory
Evaluator: 83411 83417 pathways, and
Unum Zia FSC Belgium 83432 83453 for the creation
Shamsi Issue Date: 12-01-2018 83456 83459 of complete
83513 83516 AV block in
83701 83702 atrial
83703 83704 arrhythmias.
83708

Class D

Shelf Life : 03 years

Fee- Rs. 50,000/-

251. -do- Name of Manufacturer/ FlexAbility ® Sensor Intended for Approved.
i) St. Jude Medical Enabled Catheter creating
Evaluator: 5050 Nathan Lane North lesions during
Unum Zia Plymouth, MN USA Models cardiac
Shamsi 55442 A-FASE-DD, A-FASE- ablation
DF, A-FASE-FF, A- procedures
ii) St. Jude Medical Costa FASE-FJ, A-FASE-JJ, A- (mapping,
Rica Ltda. FASE-D, A-FASE-F, A- stimulation,
Edificio No. 44 Calle 0, FASE-J and ablation)
Ave. 2, Zona Franca for the
Coyol, EI Coyol, Alajuela Class D treatment of
COSTA RICA 1897-4050 arrhythmias.
Shelf Life : 36 Months Used with
FSC USFDA compatible
Valid upto 27-3-2020 Fee- Rs. 50,000 magnetic
tracking
systems to
enable catheter
positioning
and
navigation.
252. -do- Name of Manufacturer/ FlexAbility® Ablation Intended for Approved.
i) St. Jude Medical Catheter creating focal
Evaluator: 5050 Nathan Lane North endocardial
178
 Unum Zia Plymouth, MN USA Models lesions during
Shamsi 55442 A701124, A701125, cardiac
A701127, A701128, ablation
ii) St. Jude Medical Costa A701129, A701157, procedures
Rica Ltda. A701158, A701159 (mapping,
Edificio No. 44 Calle 0, stimulation,
Ave. 2, Zona Franca Class D and ablation)
Coyol, EI Coyol, Alajuela for the
COSTA RICA 1897-4050 Shelf Life : 36 Months treatment of
arrhythmias.
FSC USFDA Fee- Rs. 50,000
Valid upto 27-3-2020

253. -do- i) St. Jude Medical Costa Livewire ® Streerable Electrophysiol Approved.
Rica Ltda. Electrophysiology ogy Catheter.
Evaluator: Edificio No. 44 Calle 0, Catheter.
Hafiz Ave. 2, Zona Franca
Muhammad Asif Coyol, EI Coyol, Alajuela 401572, 401578, 401580,
Iqbal COSTA RICA 187-4050 401581, 401582, 401586,
401600, 401603, 401606,
ii) St. Jude Medical 401648, 401652, 401653,
14901 DEVEAU PL. 401654, 401655, 401780,
MINNETONKA, MN 401781, 401782, 401786,
USA 55345 401904, 401905, 401908,
401914, 401915, 401917,
iii) St. Jude Medical 401918, 401923, 401926,
5050 Nathan Lane North 401932, 401933, 401934,
Plymouth, MN USA 401935, 401938, 401939,
55442 401940, 401941, 401942,
401949, 401990, 402019,
FSC USFDA valid till 29- 402022, 402023, 402024,
01-2020 402032
Rs. 50,000
Class D
Shelflife : 03 years

254. -do- Legal and Original AdvisorTM FL Circular The advisor Approved.
Manufacturer Mapping Catheter, FL, SE catheter
Evaluator: Sensor Enabled is a sensor-
Muhammad i) St. Jude Medical 5050, (Circular Mapping enabled
Ayub Naveed. Nathan Lane North Catheter) steerable
Plymouth, MN USA electrophysiol
55442 D-AVSE-010-F15, D- ogy catheter
AVSE-010-F20, D- used for
Manufacturing Sites: AVSEDF10-F15, D- recording
M/s. St. Jude Medical AVSE-DF10-F20 intracardia
Costa Rica Ltda, Edificio signals and
# 44 Calle O, Ave. 2, Class D cardiac
Zona Franca Coyol, EI Shelf Life 18 months stimulation
Coyol, Alajuela Costa during
Rica 187-4050 diagnostic
179
 electrophysiol
b) M/s. St. Jude Medical ogy studies.
5050, Nathan Lane North
Plymouth, MN USA
55442

FSC USFDA
Valid till November 07,
2019

255. -do- Manufacturer Peel Away Introducers Peel-away Approved.

(Peel away introducers) Hemostasis
Evaluator: M/s. St. Jude Medical Introducers
Muhammad 14901 DEVEAU PL 405100, 405104, 405108, are intended
Ayub Naveed Minnetonka, MN USA 405112, 405116, 405118, for the
55345 405119, 405120, 405122, introduction of
405124, 405128, 405129, angiographic
Legal Manufacturing 405132, 405136, 405144, catheters,
Site 405145, 405146, 405147, closed end
M/s. St. Jude Medical 405149, 405153, 405154, catheters,
5050 Nathan Lane North 405254, 405256, 405258, balloon
Plymouth, MN USA 405259, 405269, 405270, catheters, and
55442 405400, 405404, 405408, electrodes into
405412, 405418, 405420, a vessel where
FSC USFDA 405422, 405424, 405428, minimizing
Valid till October 08, 405444 blood loss is
2020 essential.
Class D
Shelf Life : 03 Years

256. -do- Legal and Original Assurity MRI Implantation Approved.

Manufacturer (Pacemaker) of a single-
Evaluator: chamber pulse
Muhammad i) M/s. St. Jude Medical PM 1272, PM 2272 generator or
Ayub Naveed Puerto LLc, Lot A dual-chamber
Interior #2 Rd km.67.5, Class D pulse
Santana Industrial Park, Not mentioned generator, or
Arecibo PR 00612, USA CRT-P is
indicated in
ii) M/s. St. Jude Medical one or more of
Operations(M) sdn. Bhd the following
Plot 102, Lebuhraya permanent
Kampung Jawa, Bayan condition:
Lepas Industrial Zone, i) Syncope
11900 Penang, Malaysia. ii) Presyncope
iii) Fatigue
iv)
FSC USFDA Disorientation
Valid till March 06, 2019 v) or any
combination of
Rs. 50,000 above
180
 symptoms.

257. -do- Legal Manufacturer / CPS AimTM SL The CPS Approved.

Manufacturing Site (Sittable Inner Catheter) delivery tools
Evaluator: with integrated valve help provide
Muhammad M/s. St. Jude Medical access to the
Ayub Naveed Cardiac Rhythm DS2N021-59, DS2N022- venous system
Management Division, 59, and aid in the
15900 Valley View Court, DS2N023-59, DS2N021- delivery of the
Sylmar, CA 91342 USA 65, DS2N022-65, left ventricular
DS2N023-65, lead during
Applicant for certificate: DS2N024-65, DS2N025- cardiac
M/s. St. Jude Medical 65, Resynchroniza
Coordination Center tion Therapy
BVBA, The Corporate Class D (CRT)
Village, Da Vincilaan 11 Shelf Life : 03 Years procedure.
box F1, 1935 Zaventem,
Belgium.

FSC Belgium
Issue date : November
07, 2017

Rs. 50,000

258. M/s. Iqbal & Manufacturer Microseld PEBAX Arterial Approved

Company M/s. Intra special (Arterial Catheter Kit) catheter for subject to
Alfalah Manzil catheters GmbH, arterial blood provision of
Opp. National OststraBe 2, 305 043 3F- 4cm pressure differential
Police 66780 Rehlingen measurement fee Rs.
Foundation, Siersburg/ Germany. 305 053 3F- 5cm and blood gas 25000/-
Street No.26, analysis, using
Sector E-11/4, FSC Germany 305 063 3F - 6cm the seldinger
Islamabad. Issued on 10.01.2019 technique.
305 064 4F - 6cm
(ELI-00117)
305 083 3F - 8cm
Evaluator:
Unum Zia 305 084 4F- 8cm
Shamsi
305 113 3F - 11cm

305 114 4F - 11cm

305 153 3F- 15cm

305 154 4F- 15cm

305 203 3F- 20cm

305 204 4F- 20cm

181
 Class D

Shelf Life : 05 years

Fee submitted: Rs.

25,000

259. -do- Manufacturer Microseld PTFE Arterial Approved.

M/s. Intra special (Arterial Catheter Kit) catheter for
Evaluator: catheters GmbH, arterial blood
Unum Zia OststraBe 2, 302 022 — 2F-2cm pressure
Shamsi 66780 Rehlingen 302 032 — 2F-3cm measurement
Siersburg/ Germany. 302 042 — 2F-4cm and blood gas
302 043 — 3F-4cm analysis, using
FSC Germany 302 062 — 2F-6cm the seldinger
Issued on 10.01.2019 302 063 — 3F-6cm technique.
302 064 — 4F-6cm
302 065— 5F-6cm
302 082— 2F-8cm
302 083— 3F-8cm
302 084— 4F-8cm
302 085— 5F-8cm
302 113— 3F-11cm
302 114— 4F-11cm
302 115— 5F-11cm
302 153— 3F-15cm
302 154— 4F-15cm
302 155— 5F-15cm
302 203— 3F-20cm
302 204— 4F-20cm
302 205— 5F-20cm

Class D
Shelf Life: 05 years
Fee submitted Rs.
50,000

260. M/s. Medicamp M/s. Genicon GeniClip™ Intended for Approved

International. 6869 Stapoint Ct., Suite (Titanium Hemostatic use during subject to
Office No. 1, 114, Winter Park, Florida Clip) procedures for provision of
First Floor, Raja 32792 USA the purpose of Stability
Naseer Plaza, 350-000-103 GeniClip approximating studies
Mohalla Raja (FSC US FDA valid 27- Medium/ Large soft tissues, supporting
Yousaf, New 11-2019) 350-000-104 GeniClip closing of shelf life.
Abadi Morgah, Large vessels and
Rawalpindi. other
Class C structures in
(ELI-00200) order to stop
Shelf life: 03 years bleeding or to
Evaluator: connect
182
 Unum Zia Fee submitted: Rs. internal tissues
Shamsi 50,000/- to aid in
healing
261. M/s. Medicamp M/s. Genicon GeniClip Applier™ Applied in Approved.
International, 6869 Stapoint Ct., Suite (Reusable) endoscopic
Office No. 1, 114, Winter Park, Florida procedures for
First Floor, Raja 32792 USA 350-010-001 GeniClip occlusion of
Naseer Plaza, Applier vessels and
Mohalla Raja (FSC US FDA valid 27- 350-010-002 GeniClip other small
Yousaf, New 11-2019) Applier tissue
Abadi Morgah, 350-010-003 GeniClip structures as
Rawalpindi. Applier well as for
radiographic
(ELI-00200) Class B markings

Evaluator: Shelf life: 200

Unum Zia sterilization cycles
Shamsi
Fee submitted: Rs.
25,000/-

262. -do- M/s. Genicon GeniFlow™ To provide Approved.

6869 Stapoint Ct., Suite suction and
(Single Use Suction
Evaluator: 114, Winter Park, Florida irrigation
/Irrigation System-
Unum Zia 32792 USA function to
Gravity)
Shamsi help flush
(FSC US FDA valid 27- blood and
11-2019) 1. 700-000-005 tissue debris
GeniFlow from the
Gravity single spike operative site
suction during
irrigation no probe laproscopy to
aid
2. 700-005-010 visualization
GeniFlow
Gravity Single Spike
Suction
Irrigation With 5x33
Probe

3. 700-005-005
GeniFlow
Gravity Single Spike
Suction
Irrigation With 5x28
Probe

4. 700-005-010
GeniFlow
Gravity Dual Spike
Suction
Irrigation With 5x33
183
 Probe

5. 700-005-033 Single
Use
Suction Irrigation Probe
5x33

6. 700-005-045 Single
Use
Suction Irrigation Probe
5x45

7. 700-010-005
GeniFlow
Gravity Dual Spike
Suction
Irrigation with 10x33
Probe

8. 700-010-033 Single
Use
Suction Irrigation Probe
10x33

9. 700-105-010
GeniFlow
Gravity Dual Spike
Suction
Irrigation with 5x33
and
10x33 Probe

10. 700-000-010
GeniFlow
Gravity single spike
suction
irrigation with 5x33

Class B
Shelf life: 3.5 years
Fee submitted: Rs.
25,000/-

263. -do- M/s. Genicon GeniSurge® Sterile, Approved.

6869 Stapoint Ct., Suite (Monopolar 5mm packaged
Evaluator: 114, Winter Park, Florida Disposable single-use
Unum Zia 32792 USA Laparoscopic monopolar
Shamsi Instrument) instruments
(FSC US FDA valid 27- including
11-2019) Curved Maryland graspers,

184
 Dissector dissectors and
Non Ratcheting 533- scissors
005-905 intended to
Atraumatic Fenestrated grasp,
Grasper manipulate,
Ratcheting 533-005-920 cut and
Babcock grasper caurterize soft
Ratcheting 533-005-925 tissue
Maxi grip fenestrated
grasper
Ratcheting 533-005-945
Straight scissors
533-005-935
Curved Metzenbaum
scissors
533-005-910

Class C

Shelf Life: 03 years

Fee submitted: Rs.

50,000/-

264. -do- M/s. Genicon Natura™ Intended for Approved.

6869 Stapoint Ct., Suite (Natura Optical surgical
Evaluator: 114, Winter Park, Florida Bladeless Trocar) insertion into
Unum Zia 32792 USA the peritoneal
Shamsi  210-005-050 Natura cavity for the
(FSC US FDA valid 27- 5x70 Trocar purpose of
11-2019)  210-005-051 Natura establishing a
5x70 Trocar with 1 port of entry
cannula threaded for
 210-005-052 Natura instrumentatio
5x70 Trocar with 2 n and for
cannula threaded visualization
 210-005-150 Natura during
5x100 Trocar laparoscopic
 210-005-151 Natura for primary
5x100 Trocar with 1 and secondary
cannula threaded insertion.
 210-005-152 Natura
5x100 Trocar with 2
cannula threaded
 210-005-250 Natura
5x150 Trocar
 210-005-251 Natura
5x150 Trocar with 1
cannula threaded
 210-005-252 Natura
5x150 Trocar with 2
185
 cannula threaded
 210-010-150 Natura
10x100 Trocar
 210-010-151 natura
10x100 Trocar with
1 cannula threaded
 210-010-152 natura
10x100 Trocar with
2 cannula threaded
 210-010-250 natura
10x150 Trocar
 210-010-251 natura
10x150 Trocar with
1 cannula threaded
 210-010-252 natura
10x150 Trocar with
2 cannula threaded
 210-012-150 natura
12x100 Trocar
 210-012-151 natura
12x100 Trocar with
1 cannula threaded
 210-012-250 natura
12x150 Trocar
 210-012-251 natura
12x150 Trocar with
1 cannula threaded
 210-015-150 natura
15x100 Trocar
 210-015-151 natura
15x100 Trocar with
1 cannula threaded
 210-015-250 natura
15x150 Trocar
 210-015-251 natura
15x50 Trocar with 1
cannula threaded
 210-103-051 Natura
3x60 trocar with 1
cannula smooth.
 210-105-052 natura
5x70 Trocar with 2
cannula smooth
 210-105-051natura
5x70 Trocar with 1
cannula smooth.
 210-105-151 natura
5x100 Trocar with 1
cannula smooth
 210-105-152 natura

186
 5x100 Trocar with 2
cannula smooth
 210-105-251 natura
5x150 Trocar with 1
cannula smooth
 210-105-252 natura
5x150 Trocar with 2
cannula smooth
 210-110-151 natura
10x100 Trocar with
1 cannula smooth
 210-110-152 natura
10x100 Trocar with
2 cannula smooth
 210-110-251 natura
10x150 Trocar with
1 cannula smooth
 210-110-252 natura
10x150 Trocar with
2 cannula smooth
 210-112-151 natura
12x100 Trocar with
1 cannula smooth
 210-115-251 natura
15xp/'150 Trocar
with 1 cannula
smooth

Class B

Shelf Life: 05 years

Fee submitted: Rs.

25,000/-

265. M/s. Easha Manufacturer/ Cocoon Septal Occluder It is Approved.

Enterprises. Manufacturing site: percutaneous,
Office No 376, M/s. Vascular Codes:- transcatheter,
Pak Khaleej Innovations Co. Ltd., 1. COA08 atrial septal
Center Saidpur 88/38 Moo 1, 345 Road, 2. COA10 defect (ASD)
Road, Bangtanai Pakkret, 3. COA12 closure device
Rawalpindi. Nonthaburi-11120 4. COA14 intended for
Thailand 5. COA16 the occlusion
(ELI-00203) 6. COA18 of secundum
FSC U.K 7. COA20 type ASD.
Evaluator: Issued on 26-11-2018 8. COA22
Unum Zia 9. COA24
Shamsi FSC Thailand 10. COA26
Valid till 07-06-2020 11. COA28
12. COA30
13. COA32

187
 14. COA34
15. COA36
16. COA38
17. COA 40

Class D

Shelf Life : 03 years

Fee --Rs. 50,000

266. -do- Manufacturer/ COCOON PFO It is a Approved.

Manufacturing site: Occulder percutaneous,
Evaluator: M/s. Vascular transcatheter
Unum Zia Innovations Co. Ltd., Codes: closure device
Shamsi 88/38 Moo 1, 345 Road, 1. CPF18 intended for
Bangtanai Pakkret, 2. CPF25 the occlusion
Nonthaburi-11120 3. CPF30 of normal and
Thailand 4. CPF35 aneurysm type
PFOs.
FSC U.K
Issued on 26-11-2018 Class D
Shelf Life : 03 years

FSC Thailand Fee --Rs. 50,000

Valid till 07-06-2020

267. -do- Manufacturer/ Cocoon VSD Occluder It is a Approved.

Manufacturing site: percutaneous,
Evaluator: M/s. Vascular 1. COV0404 transcatheter
Unum Zia Innovations Co. Ltd., 2. COV0604 ventricular
Shamsi 88/38 Moo 1, 345 Road, 3. COV0804 septal defect
Bangtanai Pakkret, 4. COV1004 (VSD) closure
Nonthaburi-11120 5. COV1204 device
Thailand 6. COV0407 intended for
7. COV0607 the occlusion
FSC U.K 8. COV0807 of
Issued on 26-11-2018 9. COV1007 hemodynamic
10. COV1207 ally significant
FSC Thailand 11. COV0410 ventricular
Valid till 07-06-2020 12. COV0610 septal defects.
13. COV0810
14. COV1010
15. COV1210

Class D

Shelf Life : 03 years

Fee --Rs. 50,000

268. -do- Manufacturer/ Cocoon Duct Occluder It is a Approved.

188
 Manufacturing site: percutaneous
Evaluator: M/s. Vascular 1. COP0406 transcatheter
Unum Zia Innovations Co. Ltd., 2. COP0608 device
Shamsi 88/38 Moo 1, 345 Road, 3. COP0810 specially
Bangtanai Pakkret, 4. COP1012 designed for
Nonthaburi-11120 5. COP1214 closure of
Thailand 6. COP1416 normally
7. COP1618 located patent
FSC U.K 8. COP1820 ductus
Issued on 26-11-2018 arteriosus with
Class D the narrowest
FSC Thailand diameter
Valid till 07-06-2020 Shelf Life : 03 years ranging from
2mm to 16mm.
Fee --Rs. 50,000 Treatment is
also feasible in
pediatric
population.
269. M/s. Optisurg Manufacturer Medicontur Aspheric Approved
17- C1, Valencia M/s. Medicontur hydrophylic subject to
Town, Lahore. Medical Engineering Bi-Flex M: 677MY acrylic foreign
Ltd., Herceghalmi Road multifocal inspection
(ELI-00305) I, 2072 Zsambek, Class C intraocular abroad. The
Hungary. lens with blue Board also
Evaluator: Shelf Life : 05 years light filter for authorized
Unum Zia FSC Hungary implantation the Secretary
Shamsi Issued on 31-01- 2018 Fee--Rs. 50,000 into capsular MDB to issue
bag. registration
of product if
the
manufacturin
g plant is
approved by
the panel of
experts.

270. -do- Manufacturer Medicontur Aspheric Approved

M/s. Medicontur Bi Flex Pre loaded: 677P hydrophylic subject to
Evaluator: Medical Engineering acrylic foreign
Unum Zia Ltd., Herceghalmi Road Class C intraocular inspection
Shamsi I, 2072 Zsambek, lens for MedJet abroad. The
Hungary. Shelf Life : 03 years Preloaded Board also
injection authorized
FSC Hungary Fee-- Rs. 50,000 system the Secretary
Issued on 31-01- 2018 (Capsular MDB to issue
fixation) registration
of product if
the
manufacturin
g plant is
approved by
the panel of
189
 experts.

271. -do- Manufacturer Medicontur Aspheric Approved

M/s. Medicontur Bi Flex: 677AB hydrophylic subject to
Evaluator: Medical Engineering acrylic foreign
Unum Zia Ltd., Herceghalmi Road Class C foldable inspection
Shamsi I, 2072 Zsambek, intraocular abroad. The
Hungary. Shelf Life : 05 years lens for Board also
implantation authorized
FSC Hungary Fee--Rs. 50,000 into capsular the Secretary
Issued on 31-01- 2018 bag. MDB to issue
registration
of product if
the
manufacturin
g plant is
approved by
the panel of
experts.

272. M/s. MED Lab Manufacturer: Cluster: Diabetes assay Insulin(e) Decision:
Services, Office M/s. Immunotech s.r.o. IRMA kit: Deferred.
No. 1, First Floor, Radiova 1122/1, 102 00 1. Insulin(e) IRMA kit Immunoradio The board
ABC Plaza, Praha, Czech Republic Size: 100 tests metric assay discussed the
Commecial Code: IM3210 for the in vitro matter at
Center, Satellite FSC Czech Republic determination length and
Town, Valid until 31-03-2021 2. C-PEPTIDE IRMA of insulin in decided that
Rawalpindi. kit human serum since
Size: 100 tests and plasma. products are
(ELI-00056) Code: IM3639 For in vitro already
diagnostic use. grouped as
Evaluator: Class B Kits,
Unum Zia C-Peptide therefore, as
Shamsi Shelf Life: 13 weeks IRMA kit: per para 2 of
Immunoradio Schedule B of
Fee submitted: Rs. metric assay Medical
25,000/- for the in vitro Devices
determination Rules, 2017
of c-peptide in can only
human serum, grouped in
plasma and one of the
urine. For in catagories,
vitro namely,
diagnostic use. single, set,
system,
family, in-
vitro test kit
or in-vitro
cluster.
Reagents and
articles can
be grouped
190
 as clusters.
Firm has
applied
multiple kits
as
CLUSTERS.
Board
directed the
firm to apply
these kits
separately.
273. -do- Legal Manufacturer: Cluster: Cancer Marker CEA IRMA Deferred.
M/s. Immunotech s.r.o. Cluster KIT: The board
Evaluator: Radiova 1122/1, 10227 1. CEA IRMA KIT Immunoradio discussed the
Unum Zia Praha, Czech Republic Size: 100 tests metric assay matter at
Shamsi Code: IM2204 for the in vitro length and
FSC Czech Republic Shelf life: 13 weeks determination decided that
Valid until 14-02-2023 2. CEA IRMA KIT of since
Fee submitted: Rs. Size: 400 tests carcinoembryo products are
25,000/- Code: IM2274 nic antigen already
Shelf life: 13 weeks (CEA) in grouped as
3. IRMA CA125 human serum. Kits,
antigen for in vitro therefore, as
Size: 100 tests diagnostic use. per para 2 of
Code: IM2233 Schedule B of
Shelf life: 09 weeks IRMA CA125 Medical
4. IRMA CA125 antigen: Devices
antigen Immunoradio Rules, 2017
Size: 50 tests metric assay can only
Code: B64312 for the in vitro grouped in
Shelf life: 09 weeks determination one of the
5. IRMA MUC-1 gene of ca 125 catagories,
associated antigen (CA antigen in namely,
15-3) Size: 100 tests human serum single, set,
Code: IM2397 and plasma. system,
Shelf life: 09 weeks for in vitro family, in-
6. IRMA MUC-1 gene diagnostic use. vitro test kit
associated antigen (CA or in-vitro
15-3) Size: 50 tests IRMA MUC-1 cluster.
Code: B64314 gene Reagents and
Shelf life: 09 weeks associated articles can
7. IRMA CA 19-9 antigen be grouped
antigen (CA15- as clusters.
Size: 100 tests 3):immunoradi Firm has
Code: IM3151 ometric assay applied
Shelf life: 09 weeks for the in vitro multiple kits
8. IRMA CA 19-9 determination as
antigen of MUC-1 gene CLUSTERS.
Size: 50 tests associated Board
Code: B64313 antigen (CA directed the
Shelf life: 09 weeks 15-3) in human firm to apply
serum and these kits
191
 plasma. For in separately.
Class B vitro The Board
diagnostic use. also decided
to classify
IRMA CA 19-9 cancer
antigen: marker as
Immunoradio Class C
metric assay medical
for the in vitro device.
determination
of CA 19-9
antigen in
human serum.
For in vitro
diagnostic use.
274. -do- Legal Manufacturer: Cluster: Fertility- RIA Decision:
M/s. Immunotech s.r.o. Pregnancy Hormone ESTRADIOL: Deferred.
Evaluator: Radiova 1122/1, 10227 Protein. Radioimmuno The board
Unum Zia Praha, Czech Republic assay for the in discussed the
Shamsi 1.RIA ESTRADIOL vitro matter at
FSC Czech Republic Size: 100 tests determination length and
Valid until 14-02-2023 Code: A21854 of oestradiol in decided that
Shelf life: 12 weeks human serum since
and plasma. products are
2.RIA ESTRADIOL For in vitro already
Size: 50 tests diagnostic use. grouped as
Code: B89462 Kits,
Shelf life: 12 weeks ACTIVE FREE therefore, as
TESTOSTER per para 2 of
3.FREE ONE RIA: Schedule B of
TESTOSTERONE Radioimmuno Medical
RIA assay for the Devices
Size: 100 tests quantitative Rules, 2017
Code: DSL-4900 measurement can only
Shelf life: 16 weeks of free grouped in
testosterone in one of the
4.PROLACTIN IRMA human serum catagories,
KIT this assay is namely,
Size: 100 tests intended for in single, set,
Code: IM2121 vitro system,
Shelf life: 13 weeks diagnostic use. family, in-
vitro test kit
5.PROLACTIN IRMA PROLACTIN or in-vitro
KIT IRMA KIT: cluster.
Size: 400 tests Immunoradio Reagents and
Code: IM3303 metric assay articles can
Shelf life: 13 weeks for the in vitro be grouped
determination as clusters.
6.RIA of prolactin in Firm has
TESTOSTERONE human serum applied
direct and plasma. multiple kits
Size:100 tests For in vitro as
192
Code: IM1119 diagnostic use. CLUSTERS.
Shelf life: 12 weeks Board
RIA directed the
7.RIA TESTOSTER firm to apply
PROGESTERONE ONE direct: these kits
kit Radioimmuno separately.
Size: 100 tests assay for the in
Code: IM1188 vitro
Shelf life: 12 weeks determination
of total
8.LH IRMA kit testosterone in
Size: 100 tests human serum
Code: IM1381 and plasma for
Shelf life: 13 weeks in vitro
diagnostic use.
9.LH IRMA kit
Size: 400 tests RIA
Code: IM3302 PROGESTER
Shelf life: 13 weeks ONE kit:
Radioimmuno
10. RIA 17α- assay for the in
Hydroxyprogestero vitro
ne determination
Size: 100 tests of
Code: IM1452 progesterone
Shelf life: 12 weeks in human
serum and
plasma. for in
11. hCG IRMA kit vitro
Size:100 tests diagnostic use.
Code: IM2110
Shelf life: 12 weeks LH IRMA kit:
Immunoradio
12. hCG IRMA kit metric assay
Size: 400 tests for the in vitro
Code: IM2209 determination
Shelf life: 12 weeks of luteinizing
hormone in
13. FSH IRMA KIT human serum
Size: 100 tests and plasma.
Code: IM2125 for in vitro
Shelf life: 12 weeks diagnostic use.

14. FSH IRMA KIT RIA 17α-

Size: 400 tests Hydroxyproge
Code: IM3301 sterone:
Shelf life: 12 weeks Radioimmuno
assay for the in
vitro
determination
of 17α-
hydroxyproge
193
 sterone in
human serum
and plasma.
for in vitro
diagnostic use.

hCG IRMA
kit:
Immunoradio
metric assay
for the in vitro
determination
of human total
chorionic
gonadotropin
(HCG) in
human serum
and plasma.
for in vitro
diagnostic use.

FSH IRMA
kit:
Immunoradio
metric assay
for the in vitro
determination
of FSH in
human serum
and plasma.
for in vitro
diagnostic use.
275. -do- Legal Manufacturer: Cluster: Thyroid Thyroglobulin Decision:
M/s. Immunotech s.r.o. function markers IRMA kit: Deferred.
Evaluator: Radiova 1122/1, 10227 Immunoradio The board
Unum Zia Praha, Czech Republic 1. Thyroglobulin metric assay discussed the
Shamsi IRMA kit for the in vitro matter at
FSC Czech Republic determination length and
Size: 100 tests
Valid until 14-02-2023 of decided that
Code: A85726
thyroglobulin since
Shelf life: 08 weeks
Fee submitted: Rs. (tg) in human products are
25,000/- serum and already
2. Anti-TPO RIA kit plasma. for in grouped as
vitro Kits,
Size: 100 tests diagnostic use. therefore, as
Code: A56719 per para 2 of
Shelf life: 10 weeks Anti-TPO RIA Schedule B of
kit: Medical
Radioimmuno Devices
3. IRMA PTH assay for the in Rules, 2017
vitro can only
Size: 100 tests determination grouped in
194
Code: A11930 of antibodies one of the
Shelf life: 08 weeks against thyroid catagories,
peroxidase namely,
(anti-TPO) in single, set,
4. IRMA PTH human serum. system,
for in vitro family, in-
Size:50 tests
diagnostic use. vitro test kit
Code: B89461
or in-vitro
Shelf life: 08 weeks
IRMA PTH: cluster.
Immunoradio Reagents and
metric assay articles can
5. FT4 RIA kit
for the in vitro be grouped
Size: 100 tests determination as clusters.
Code: IM1363 of parathyroid Firm has
Shelf life: 11 weeks hormon in applied
human serum multiple kits
and plasma. as
6. FT4 RIA kit for in vitro CLUSTERS.
diagnostic use. Board
Size: 400 tests directed the
Code: IM3321 FT4 RIA kit: firm to apply
Shelf life: 11 weeks Radioimmuno these kits
assay for the in separately.
vitro
7. RIA FT3 kit
determination
Size: 100 tests of free
Code: M1579, thyroxine in
Shelf life: 12 weeks human serum
and plasma.
for in vitro
8. RIA FT3 kit diagnostic use.

Size: 400 tests RIA FT3 kit:

Code: IM3320 Radioimmuno
Shelf life: 12 weeks assay for the in
vitro
determination
9. TOTAL T3 RIA KIT of free
Size: 100 tests triiodothyroni
Code: IM1699 ne in human
Shelf life: 14 weeks serum and
plasma. For in
vitro
10. TOTAL T3 RIA KIT diagnostic use.

Size: 400 tests TOTAL T3

Code: IM3287 RIA KIT:
Shelf life: 14 weeks Radioimmuno
assay for the in
vitro
11. Anti-hTg IRMA KIT determination
of total
195
 Size: 100 tests triiodothyroni
Code: IM3223 ne (TT3) in
Shelf life: 13 weeks human serum
and plasma.
for in vitro
12. TSH IRMA kit diagnostic use.
Size: 100 tests
Anti-hTg
Code: IM3712
IRMA KIT:
Shelf life: 10 weeks
immunoradio
metric assay
for the in vitro
13. TSH IRMA kit
determination
Size: 400 tests of
Code: IM3713 autoantibodies
Shelf life: 10 weeks anti-hTg in
human serum
and plasma.
14. Total T4 RIA kit for in vitro
diagnostic use.
Size: 100 tests
Code: IM1447 TSH IRMA
Shelf life: 14 weeks kit:
Immunoradio
metric assay
15. Total T4 RIA kit
for the in vitro
Size: 400 tests determination
Code: IM3286 of thyroid-
Shelf life: 14 weeks stimulating
hormone in
Class B human serum
and plasma.
For in vitro
diagnostic use.

Total T4 RIA
kit:Radioimm
unoassay for
the in vitro
determination
of total
thyroxine
(TT4) in
human serum
and plasma.
for in vitro
diagnostic use

276. M/s Medtronic Owner Operator/ Endeavor Resolute Drug Eluting Approved
Pakistan Legal Manufacturer: Zotarolimus Eluting Stent and with
(Private) M/s Medtronic Inc., 710 Coronary Stent System Delivery cancellation
Limited, Office Medtronic Parkway NE, System as drug.
196
 No.1301, 13th Minneapolis MN 55432, Class D
Floor Dilkusha USA
Shelf Life: 2 Years
Forum Tariq
Road, Karachi Manufacturer: ERES22508X Endeavor
M/s Medtronic Ireland, Resolute 2.25x8mm
(ELI-00273) Parkmore Business Park ……………..
West, Galway, Ireland Codes & Sizes as per
Evaluator: FSC.
Hafiz (FSC Ireland Valid Till Rs.50,000/-
Muhammad Asif 14-08-2022)
Iqbal

277. -do- Owner Operator/ Sprinter NC/SC RX PTCA Balloon Approved

Legal Manufacturer: Balloon Dilatation Dilatation with
Evaluator: M/s Medtronic Inc., 710 Catheter Catheter cancellation
Hafiz Medtronic Parkway NE, as drug.
Muhammad Asif Minneapolis MN 55432, Class D
Iqbal USA
Shelf Life: 2 Years
Manufacturer: Codes & sizes as per
M/s Medtronic Mexico FSC.
S. de R.L. de CV, Av.
PAseo Cucapah 10510 El
NCSP2006X …………..
Lago, C.P. 22210 Tijuana,
Baja California, Mexico
Rs.50,000/-
(FSC Ireland Valid Till
16-08-2022)
278. -do- Owner Operator/ Resolute Onyx Zotarolimus- Approved
Legal Manufacturer: Zotarolimus-Eluting Eluting with
Evaluator: M/s Medtronic Inc., 710 Coronary Stent System Coronary Stent cancellation
Hafiz Medtronic Parkway NE, System as drug.
Muhammad Asif Minneapolis MN 55432, Class D
Iqbal USA
Shelf Life: 2 Years
Manufacturer: RONYX30026X
M/s Medtronic Ireland, 3.0x26mm ……………
Parkmore Business Park Codes & sizes as per
West, Galway, Ireland FSC.
Rs.50,000/-
(FSC Ireland Valid Till
27-07-2022)
279. -do- Owner Operator/ EuphoraTM Rapid PTCA Balloon Approved
Legal Manufacturer: Exchange Balloon Dilatation with
Evaluator: M/s Medtronic Inc., 710 Dilatation Catheter Catheter cancellation
Hafiz Medtronic Parkway NE, product as drug.
Muhammad Asif Minneapolis MN 55432, Class D Family
Iqbal USA
Shelf Life: 2 Years
Manufacturer: EUP 1506X …….
M/s Medtronic Mexico Codes & sizes as per
S. de R.L. de CV, Av. FSC.
197
 PAseo Cucapah 10510 El
Lago, C.P. 22210 Tijuana, Rs.50,000/-
Baja California, Mexico .

(FSC Ireland Valid Till

01-06-2023)
280. -do- Owner Operator/ Export Advance TM Aspiration Approved
Legal Manufacturer: Aspiration Catheters Catheter with
Evaluator: M/s Medtronic Inc., 710 cancellation
Hafiz Medtronic Parkway NE, Class D as drug.
Muhammad Asif Minneapolis MN 55432,
Shelf Life: 2 Years
Iqbal USA
Codes & sizes as per
Manufacturer: FSC.
M/s Medtronic Vascular,
37A Cherry Hill Drive,
Rs.50,000/-
Danvers, MA 01923,
USA.

(FSC Ireland Valid Till

24-08-2021)

281. -do- Owner Operator/ Sprinter Legend RX Balloon Approved

Legal Manufacturer: Balloon Dilatation Dilatation with
Evaluator: M/s Medtronic Inc., 710 Catheter Catheter cancellation
Hafiz Medtronic Parkway NE, as drug.
Muhammad Asif Minneapolis MN 55432, Class D
Iqbal USA
Shelf Life: 3 Years
Manufacturer: SPL22512X ……………..
M/s Medtronic Mexico Codes & sizes as per
S. de R.L. de CV, Av. FSC.
PAseo Cucapah 10510 El
Lago, C.P. 22210 Tijuana, Fee Submitted
Baja California, Mexico Rs.50,000/-

(FSC Ireland Valid Till

10-10-2022)

282. -do- Owner Operator/ Resolute Integrity Drug Eluting Approved

Legal Manufacturer: Zotarolimus-Eluting Coronary Stent with
Evaluator: M/s Medtronic Inc., 710 Coronary Stent System and Delivery cancellation
Hafiz Medtronic Parkway NE, Resolute as drug.
Muhammad Asif Minneapolis MN 55432, Class D Integrity
Iqbal USA Zotarolimus
Shelf Life: 3 Years
Manufacturer: Eluting Rapid
M/s Medtronic Ireland, RSINT30026X Resolute Exchange
Parkmore Business Park Integrity 3.0x26mm Coronary Stent
West, Galway, Ireland …………………. System
Codes & sizes as per
198
 (FSC Ireland Valid Till FSC.
08-08-2022) Fee Submitted
Rs.50,000/-

283. M/s Krestacorp, Legal Manufacturer/ Purplex with Warming Natural Approved.
76-C, 3rd Floor, Manufacturing Site: Gel Condom Rubber Latex
Suit No.2, M/s Karex Industries Male
Khayaban-e- SDN BHD PTD. 7906 & Class C Condoms
Jami, Street No.9, 7907 Taman Pontian
DHA Phase 7, Jaya, Bt. 34, Jalan Johor, Shelf Life: 05 Years
Karachi 82000, Pontian Johor
Darul Takzim, Malaysia
(ELI-00258)
(FSC UK Issuance Date Rs.50,000/-
30-01-2019)

284. -do- Legal Manufacturer/ Klimax Flavored Natural Approved.

Manufacturing Site: Condom Rubber Latex
Evaluator: M/s Karex Industries Male
Hafiz SDN BHD PTD. 7906 & Class C Condoms
Muhammad Asif 7907 Taman Pontian
Iqbal Jaya, Bt. 34, Jalan Johor, Shelf Life: 05 Years
82000, Pontian Johor
Darul Takzim, Malaysia Klimax Orange
Flavored Condom
((FSC UK Issuance Date 81518103016
30-01-2019)
Klimax Strawberry
Flavored Condom

Klimax Banana
Flavored Condom

Klimax Tutti Frutti

Flavored Condom

Rs.50,000/-

285. -do- Legal Manufacturer/ Klimax Sensual Natural Approved.

Manufacturing Site: Condom Rubber Latex
Evaluator: M/s Karex Industries Male
Hafiz SDN BHD PTD. 7906 & Class C Condoms
Muhammad Asif 7907 Taman Pontian
Iqbal Jaya, Bt. 34, Jalan Johor, Shelf Life: 05 Years
82000, Pontian Johor
Darul Takzim, Malaysia
Rs.50,000/-
(FSC UK Issuance Date
30-01-2019)
286. -do- Legal Manufacturer/ Klimax Intense Natural Approved.
Manufacturing Site: Condom Rubber Latex
Evaluator: M/s Karex Industries Male
199
 Hafiz SDN BHD PTD. 7906 & Class C Condoms
Muhammad Asif 7907 Taman Pontian
Iqbal Jaya, Bt. 34, Jalan Johor, Shelf Life: 05 Years
82000, Pontian Johor
Darul Takzim, Malaysia GC81518103016
Rs.50,000/-
((FSC UK Issuance Date
30-01-2019)

287. -do- Legal Manufacturer/ Extasy Plus Condom Natural Approved.

Manufacturing Site: Rubber Latex
Evaluator: M/s Karex Industries Class C Male
Hafiz SDN BHD PTD. 7906 & Condoms
Muhammad Asif 7907 Taman Pontian Shelf Life: 05 Years
Iqbal Jaya, Bt. 34, Jalan Johor,
82000, Pontian Johor
Darul Takzim, Malaysia Rs.50,000/-

(FSC UK Issuance Date

30-01-2019)

288. -do- Legal Manufacturer/ Klimax Extasy Condom Natural Approved.

Manufacturing Site: Rubber Latex
Evaluator: M/s Karex Industries Class C Male
Hafiz SDN BHD PTD. 7906 & Condoms
Muhammad Asif 7907 Taman Pontian Shelf Life: 05 Years
Iqbal Jaya, Bt. 34, Jalan Johor,
82000, Pontian Johor
Darul Takzim, Malaysia Rs.50,000/-

(FSC UK Issuance Date

30-01-2019)

289. -do- Legal Manufacturer/ Klimax Ultra Condom Natural Approved.

Manufacturing Site: Rubber Latex
Evaluator: M/s Karex Industries Class C Male
Hafiz SDN BHD PTD. 7906 & Condoms
Muhammad Asif 7907 Taman Pontian Shelf Life: 05 Years
Iqbal Jaya, Bt. 34, Jalan Johor,
82000, Pontian Johor
Darul Takzim, Malaysia Rs.50,000/-

(FSC UK Issuance Date

30-01-2019)

290. -do- Legal Manufacturer/ Klimax Performax Natural Approved.

Manufacturing Site: Condom Rubber Latex
Evaluator: M/s Karex Industries Male
Hafiz SDN BHD PTD. 7906 & Class C Condoms
Muhammad Asif 7907 Taman Pontian
Iqbal Jaya, Bt. 34, Jalan Johor, Shelf Life: 05 Years
82000, Pontian Johor
200
 Darul Takzim, Malaysia
Rs.50,000/-
((FSC UK Issuance Date
30-01-2019)

291. M/s Medtronic Legal Manufacturer: Ensura SR MRI Single Approved.

Pakistan M/s Medtronic Inc., 710 SureScan Chamber
(Private) Medtronic Parkway NE, implantable
Limited, Office Minneapolis MN 55432, Class D pacemaker,
No.1301, 13th USA rate-
Shelf Life: 18 Months
Floor Dilkusha responsive
(From the date of
Forum Tariq Manufacturing Site:
power source
Road, Karachi M/s Medtronic Europe
connection)
S.a.r.l., Route du Molliau
(ELI-00273) 31, Case Postale, 1131
Model: END1SR01
Tolochenaz, Switzerland
Fee Submitted
(FSC Switzerland Valid
Rs.50,000/-
Till
06-03-2021)

292. -do- Legal Manufacturer: Syncra CRT-P Cardiac Approved.

M/s Medtronic Inc., 710 Resynchroniza
Evaluator: Medtronic Parkway NE, Class D tion Therapy
Hafiz Minneapolis MN 55432, Implantable
Shelf Life: 18 Months
Muhammad Asif USA Pacemaker
(From the date of
Iqbal (Dual
power source
Manufacturing Site: Chamber)
connection)
M/s Medtronic Europe
S.a.r.l., Route du Molliau
Model: C2TR01
31, Case Postale, 1131
Tolochenaz, Switzerland
Fee submitted
Rs.50,000/-
(FSC Switzerland Valid
Till
06-03-2021)

293. -do- Legal Manufacturer: Solara CRT-P MRI Cardiac Approved.

M/s Medtronic Inc., 710 SureScan Resynchroniza
Evaluator: Medtronic Parkway NE, tion Therapy
Hafiz Minneapolis MN 55432, Class D Implantable
Muhammad Asif USA Pacemaker
Shelf Life: 18 Months
Iqbal
(From the date of
Manufacturing Site:
power source
M/s Medtronic Europe
201
 S.a.r.l., Route du Molliau connection)
31, Case Postale, 1131
Tolochenaz, Switzerland Model: W1TR06

(FSC Switzerland Valid Fee submitted

Till Rs.50,000/-
06-03-2021)

294. -do- Owner Operator/ MiRCSP Cannulae Coronary Approved

Legal Manufacturer: (Minimally Invasive Sinus Cannula subject to
Evaluator: M/s Medtronic Inc., 710 Retrograde Cannula) provision of
Hafiz Medtronic Parkway NE, stability data.
Muhammad Asif Minneapolis MN 55432, Class D
Iqbal USA
Shelf Life: 3 Years
Manufacturing Facility: 94113TD, 94113TDT,
M/s Medtronic Mexico 94533TD, 94533TDT
S.de R.L. de CV Av. ……..
Paseo Cucapah 10510 El (Codes as per FSC)
Lago Tijuana, Baja
California CP 22210, Rs.50,000/-
Mexico

(FSC USFDA Valid Till

11-09-2019)

295. -do- Owner Operator/ DLP® PVC RCSP Retrograde Approved.

Legal Manufacturer: Cannulae with Auto- Coronary
Evaluator: M/s Medtronic Inc., 710 Inflate Cuff Sinus
Hafiz Medtronic Parkway NE, Perfusion
Muhammad Asif Minneapolis MN 55432, Class D Cannula
Iqbal USA
Shelf Life: 3 Years
Manufacturing Facility: 94523, 94533, 94535,
M/s Medtronic Mexico 94535NPL, 94835,
S.de R.L. de CV Av. 94845, 94885, 94885K,
Paseo Cucapah 10510 El 94895, 94935, 94945
Lago Tijuana, Baja
California CP 22210, Fee sumbitted
Mexico Rs.50,000/-

(FSC USFDA Valid Till

11-09-2019)

296. -do- Legal Manufacturer: Sprinter Legend Over Balloon Approved.

M/s Medtronic Inc., 710 The Wire Dilation
Evaluator: Medtronic Parkway NE, Catheter
Hafiz Minneapolis MN 55432, Class D
Muhammad Asif USA
Shelf Life: 2 Years
Iqbal
Manufacturing Facility:
202
 M/s Medtronic Ireland, SPL12506WL,
Parkmore Business Park SPL12510WL,
West Galway, Ireland SPL12512WL,
SPL12515WL,
(FSC Ireland Valid Till SPL12520WL
20-11-2022)
Rs.50,000/-
297. -do- Owner Operator: Cougar PTCA PTCA Approved.
M/s Medtronic Inc., 710 Guidewire Guidewires
Evaluator: Medtronic Parkway NE,
Hafiz Minneapolis MN 55432, Class D
Muhammad Asif USA
Shelf Life: 3 Years
Iqbal
Legal Manufacturer:
M/s Medtronic Vascular CGRLS190HJ,
37A, Cherry Hill Dr CGRLS190HS,
Danvers, MA 01923, CGRLS190J,
USA CGRLS190S,
CGRLS300HJ,
(FSC USFDAValid Till CGRLS300HS,
20-09-19) CGRLS300J,
CGRLS300S,
CGRXT190HJ,
CGRXT190HS,
CGRXT190J,
CGRXT190S,
CGRXT300HJ,
CGRXT300HS,
CGRXT300J,
CGRXT300S,
LVCLS190J,
LVCLS190S,
LVCXT190J,
LVCXT190S

Rs.50,000/-
298. -do- Legal Manufacturer: NC Euphora (Rapid Rapid Approved.
M/s Medtronic Inc., 710 Exchange Balloon Exchange
Evaluator: Medtronic Parkway NE, Dilatation Catheter ) Balloon
Hafiz Minneapolis MN 55432, Dilatation
Muhammad Asif USA Class D Catheter- Non
Iqbal Compliant
Shelf Life: 2 Years
Manufacturer:
i)M/s Medtronic Mexico NCEUP32520X,
S. de R.L. de CV, Av. NCEUP3520X,
Paseo Cucapah 10510 El NCEUP37520X,
Lago, C.P. 22210 Tijuana NCEUP4020X,
Baja California, Mexico NCEUP4520X,
NCEUP2527X,
NCEUP27527X,
(FSC Ireland Valid Till NCEUP3027X,
16-08-2022) NCEUP32527X,
203
NCEUP3527X,
NCEUP37527X,
NCEUP4027X,
NCEUP2006X,
NCEUP22506X,
NCEUP2506X,
NCEUP27506X,
NCEUP3006X,
NCEUP32506X,
NCEUP3506X,
NCEUP37506X,
NCEUP4006X,
NCEUP2008X,
NCEUP22508X,
NCEUP2508X,
NCEUP27508X,
NCEUP3008X,
NCEUP32508X,
NCEUP3508X,
NCEUP37508X,
NCEUP4008X,
NCEUP4508X,
NCEUP5008X,
NCEUP2012X,
NCEUP22512X,
NCEUP2512X,
NCEUP27512X,
NCEUP3012X,
NCEUP32512X,
NCEUP3512X,
NCEUP37512X,
NCEUP4012X,
NCEUP4512X,
NCEUP5012X,
NCEUP2015X,
NCEUP22515X,
NCEUP2515X,
NCEUP27515X,
NCEUP3015X,
NCEUP32515X,
NCEUP3515X,
NCEUP37515X,
NCEUP4015X,
NCEUP4515X,
NCEUP5015X,
NCEUP2020X,
NCEUP22520X,
NCEUP2520X,
NCEUP27520X,
NCEUP3020X

Fee Submitted
204
 Rs.50,000/-
299. -do- Legal Manufacturer: IN.PACT Falcon Paclitaxel- Approved.
M/s Medtronic Inc., 710 (Paclitaxel-eluting eluting PTCA
Evaluator: Medtronic Parkway NE, PTCA Balloon Balloon
Hafiz Minneapolis MN 55432, Catheter) Catheter
Muhammad Asif USA
Iqbal Class D
Manufacturer:
Shelf Life: 3 Years
M/s Medtronic Ireland,
Parkmore Business Park FLC P20 014 B12,
West, Galway, Ireland FLC P20 020 B12,
FLC P20 030 B12,
(FSC Ireland Valid Till FLC P22 014 B12,
24-05-2022) FLC P22 020 B12,
FLC P22 030 B12,
FLC P25 014 B12,
FLC P25 020 B12 ,
FLC P25 030 B12,
FLC P25 040 B12,
FLC P27 014 B12,
FLC P27 020 B12,
FLC P27 030 B12,
FLC P30 014 B12 ,
FLC P30 020 B12,
FLC P30 030 B12,
FLC P30 040 B12,
FLC P32 014 B12,
FLC P32 020 B12,
FLC P32 030 B12,
FLC P35 014 B12,
FLC P35 020 B12,
FLC P35 030 B12,
FLC P35 040 B12,
FLC P37 014 B12,
FLC P37 020 B12,
FLC P37 030 B12,
FLC P40 014 B12,
FLC P40 020 B12,
FLC P40 030 B12,
FLC P40 040 B12,
FLC P25 014 B22,
FLC P25 020 B22,
FLC P25 030 B22,
FLC P25 040 B22,
FLC P30 014 B22,
FLC P30 020 B22,
FLC P30 030 B22,
FLC P30 040 B22,
FLC P35 014 B22,
FLC P35 020 B22,
FLC P35 030 B22,
FLC P35 040 B22,
205
 FLC P40 014 B22,
FLC P40 020 B22,
FLC P40 030 B22,
FLC P40 040 B22

Fee Submitted
Rs.50,000/-
300. -do- Manufacturer: Core Valve Evolut R Aortic Approved.
M/s Medtronic Transcatheter Aortic Transcatheter
Evaluator: CoreValve, LLC 1851 E. Valve (Bioprosthesis) heart Valve
Hafiz Deere Ave Santa Ana, bioprosthesis,
Muhammad Asif CA 92705, USA Class D stent like
Iqbal Framework
Shelf Life: 3 Years
Manufacturing Site:
M/s Medtronic Mexico EVOLUTR-23,
S. de R.L. de CV, Av. EVOLUTR-26,
PAseo Cucapah 10510 El EVOLUTR-29,
Lago, C.P. 22210 Tijuana, EVOLUTR-34
Baja California, Mexico
Fee Submitted
Rs.50,000/-
(FSC The Netherlands
Valid Till
28-01-2020)

301. M/s Popular Manufacturer: PermacolTM Collagen Porcine Approved.

International M/s Sofradim Paste Collagen For Porcine
(Pvt) Ltd., House Production, 116 Avenue Surgical the patient
No. 141, Justice du Formans, 01600 Class D Implant written
Inamullah Road, Trevoux, France consent shall
Shelf Life: 3 years
Block 7 & 8 be taken
KMCHS, Near (FSC France Issuance prior to its
6000-300
Hill Park, Date use
Karachi 26-11-2015) according to
his / her
(ELI-00091) Fee Submitted religious
Rs.50,000/- belief system.
The Board
also
instructed to
send an
Advisory to
Provincial
Health Care
Commissions
for further
passing on
necessary
instructuions
regarding
patient
consent for
206
 usage of
Porcine.
302. -do- Manufacturer: ParietexTM Optimized Composite Approved.
M/s Sofradim Composite Mesh Sterile Mesh
Evaluator: Production, 116 Avenue with
Hafiz du Formans, 01600 Class D Absorbable
Muhammad Asif Trevoux, France Collagen Film
Shelf Life: 3 years
Iqbal
(FSC France Issuance
PCO9X, PCO12X,
Date
PCO15X, PCO20X,
30-09-2016)
PCO1510X, PCO2015X,
PCO2520X, PCO3020X,
PCO3728X, PCO9FX,
Fee Submitted
PCO12FX, PCO15FX,
Rs.50,000/-
PCO20FX, PCO1510FX,
PCO2015FX,
PCO2520FX,
PCO3020FX,
PCO3728FX, PCO8OSX,
PCO1510OSX,
PCO2015OSX,
PCO2520OSX
PCO3020OSX
303. -do- Manufacturer: SymbotexTM Composite Composite Approved.
M/s Sofradim Mesh Sterile Mesh
Evaluator: Production, 116 Avenue with
Hafiz du Formans, 01600 Class D Absorbable
Muhammad Asif Trevoux, France Collagen Film
Shelf Life: 3 years
Iqbal
(FSC France Issuance
Codes and sizes as per
Date
FSC.
30-09-2016)

Fee Submitted
Rs.50,000/-

304. -do- Manufacturer: PermacolTM Surgical Porcine Approved.

M/s Sofradim Implant Collagen For Porcine
Evaluator: Production, 116 Avenue Surgical the patient
Hafiz du Formans, 01600 Class D Implant written
Muhammad Asif Trevoux, France consent shall
Shelf Life: 5 years
Iqbal be taken
(FSC France Issuance prior to its
5000-150, 50001-150,
Date use
5000-50, 5001-50, 5033-
26-11-2015) according to
50, 5000-100, 5110-150,
his / her
5001-100, 5220-100,
religious
5033-100, 5033-150,
Rs.50,000/- belief system.
5115-150, 5110-100,
The Board
5115-100, 5120-150,
also
5418-100, 5230-150,
instructed to
5152-150, 5240-150,
207
 5250-150, 5063-150, send an
5152-100, 5120-100, Advisory to
5230-100, 5284-150, 5416 Provincial
100, 5616 100, 5816 100, Health Care
5210 100 Commissions
for further
passing on
necessary
instructuions
regarding
patient
consent for
usage of
Porcine.
305. -do- Manufacturer: ProgipTM Laparoscopic Partially Approved.
M/s Sofradim Self-Fixating Mesh Absorbable
Evaluator: Production, 116 Avenue Sterile mesh
Hafiz du Formans, 01600 Class D with
Muhammad Asif Trevoux, France Absorbable
Shelf Life: 3 years
Iqbal Collagen Film
(FSC France Issuance
LPG1510, LPG1612,
Date
LPG1614, LPG1309AR,
30-09-2016)
LPG1309AL,
LPG1510AR,
Rs.50,000/-
LPG1510AL,
LPG1612AR,
LPG1612AL,
LPG1510AK2,
LPG1510X2
306. M/s. Uniplan M/s. Allmed Medical POLYPURE Allmed Approved
Trade GMBH Mittlebacher DIALYZER (10-22) Low Hollow Fibre subject to
International Pvt Str.18, Flux, Medim Flux, High Hemo- provision of
ltd. D-01896 Pulsnits, Flux Dialyzers are shelf life
132/2 Quadi-e- Germany. (HOLLOW FIBER used for data.
Azam Industrial DIALYZER) patients with
Estate, Kot FSC Germany acute &
Lakhpt, Lahore. Issued on 10.04.2017 (Codes will be chronic renal
provided later) failure.
Fee Submitted Rs. Hemodialyzsis
50,000 Class C ;
Shelf Life : Not Hemofiltration
mentioned
307. M/s. Cor-Med, M/s. IBERHOSPIT EX, Crossway PTCA semi PTCA semi Approved.
2nd Floor 38/62 S.A Arda. Catalunya, compliant Balloon compliant
Rehman Plaza 408185 Llica de Vall Balloon
Bank Road (Barcelona) Spain Referencia / Reference
Saddar, Diámetro /
Rawalpindi. FSC Spain Diameter(mm)
Issued on June 9, 2016 Longitud / Length
(mm)

208
 Fee Submitted Fee Rs. OO64101 OO64306
50,000 OO64102 OO64307
OO64103 OO64308
OO64104 OO64309
OO64201 OO64321
OO64202 OO64322
OO64203 OO64323
OO64204 OO64324
OO64205 OO64325
OO64206 OO64326
OO64208 OO64327
OO64221 OO64328
OO64222 OO64329
OO64223 OO64351
OO64224 OO64352
OO64225 OO64353
OO64226 OO64354
OO64227 OO64355
OO64228 OO64356
OO64229 OO64358
OO64251 OO64371
OO64252 OO64372
OO64253 OO64373
OO64254 OO64374
OO64255 OO64375
OO64256 OO64376
OO64257 OO64378
OO64258 OO64401
OO64259 OO64402
OO64271 OO64403
OO64272 OO64404
OO64273 OO64405
OO64274 OO64406
OO64275 OO64408
OO64276 OO64452
OO64277 OO64453
OO64278 OO64454
OO64279 OO64455
OO64301
OO64302
OO64303
OO64304
OO64305

Class D
Shelflife : 03 years

308. -do- M/s. IBERHOSPIT EX, Crossway NC PTCA PTCA Approved.

S.A Arda. Catalunya, Dilation Catheter dialation
209
Evaluator: 408185 Llica de Vall Catheter -NC
Hafiz (Barcelona) Spain OO65201 OO65321
Muhammad Asif OO65202 OO65322
Iqbal FSC Spain OO65203 OO65323
Issued on June 9, 2016 OO65204 OO65324
OO65205 OO65325
Fee Submitted Rs. OO65206 OO65326
50,000 OO65207 OO65327
OO65208 OO65328
OO65209 OO65329
OO65221 OO65351
OO65222 OO65352
OO65223 OO65353
OO65224 OO65354
OO65225 OO65355
OO65226 OO65356
OO65227 OO65357
OO65228 OO65358
OO65229 OO65359
OO65251 OO65371
OO65252 OO65372
OO65253 OO65373
OO65254 OO65374
OO65255 OO65375
OO65256 OO65376
OO65257 OO65377
OO65258 OO65378
OO65259 OO65379
OO65271 OO65401
OO65272 OO65402
OO65273 OO65403
OO65274 OO65404
OO65275 OO65405
OO65276 OO65406
OO65277 OO65407
OO65278 OO65408
OO65279 OO65409
OO65301 OO65451
OO65302 OO65452
OO65303 OO65453
OO65304 OO65454
OO65305 OO65455
OO65306 OO65456
OO65307 OO65457
OO65308 OO65458
OO65309 OO65459

Class D
Shelflife : 03 years

210
309. -do- M/s. IBERHOSPIT EX, Iht DESing BD Sirolimus Approved.
S.A Arda. Catalunya, ( Sirolimus eluting Eluting
Evaluator: 408185 Llica de Vall Coronary Stent System) Coronary Stent
Hafiz (Barcelona) Spain System
Muhammad Asif 66228 66304
Iqbal FSC Spain 66258 66354
Issued on June 9, 2016 66278 66404
66308 66230
Fee Submitted 66358 66260
Rs. 50,000/- 66408 66280
66222 66310
66252 66360
66272 66410
66302 66232
66352 66262
66402 66282
66226 66312
66256 66362
66276 66412
66306 66236
66356 66266
66406 66286
66220 66316
66250 66366
66270 66416
66300 66234
66350 66264
66400 66284
66224 66314
66254 66364
66274 66414

Class D
Shelflife : 12 months

310. M/s. Bay-G Manufacturer : Glucolab Test Strip Blood Glucose Approved.
Pharma (Blood Monitoring Test testing strip
103-A, A Block M/s. Osang Health Care, Strip)
Satelite Town Co. Ltd.
Rawalpindi. 132, Codes N/A
Anyangcheoondong-RO,
Dongan-GU Anyangi-SI, Class C
Gyenonggi-DO 14040, Shelflife : 02 years
South Korea.

FSC South Korea

Valid till 31.01.2021

FSC Belgium
Issued on 22.01.2019
Fee Submitted
211
 Rs. 50,000/-

311. -do- Manufacturer : EasyGluco Meter Blood Glucose Approved.

(Blood Glucose monitoring
Evaluator: M/s. Osang Health Care, monitor) device
Hafiz Co. Ltd.
Muhammad Asif 132, Codes N/A
Iqbal Anyangcheoondong-RO,
Dongan-GU Anyangi-SI, Class C
Gyenonggi-DO 14040, Shelflife : N/A
South Korea.

FSC South Korea

Valid till 31.01.2021

FSC Belgium
Issued on 22.01.2019
Fee Submitted
Rs. 50,000/-

312. -do- Manufacturer : GlucoLab Meter Blood Glucose Approved.

(Blood Glucose monitoring
Evaluator: M/s. Osang Health Care, monitor) device
Hafiz Co. Ltd.
Muhammad Asif 132, Codes N/A
Iqbal Anyangcheoondong-RO,
Dongan-GU Anyangi-SI, Class C
Gyenonggi-DO 14040, Shelflife : N/A
South Korea.

FSC South Korea

Valid till 31.01.2021
FSC Belgium
Issued on 22.01.2019
Fee Submitted
Rs. 50,000/-
313. -do- Manufacturer : EasyGluco Test Strip Blood Glucose Approved.
(Blood Glucose testing strip
Evaluator: M/s. Osang Health Care, monitoring test strip)
Hafiz Co. Ltd.
Muhammad Asif 132, Codes N/A
Iqbal Anyangcheoondong-RO,
Dongan-GU Anyangi-SI, Class C
Gyenonggi-DO 14040, Shelflife : 02 years
South Korea.

FSC South Korea

Valid till 31.01.2021

FSC Belgium
Issued on 22.01.2019
Fee Submitted
212
 Rs. 50,000/-

314. M/s Roche Legal Manufacturer/ Cobas Elecsys Total Quantitative Approved.
Pakistan Manufacturing Site: PSA vitro
Limited, 37-C, M/s Roche Diagnostics diagnostic test
Bi-6, P.E.C.H.S, GmbH, Class C for total (free +
Karachi Sandhofer Str.116, 68305 complexed)
Mannheim, Germany i) Cobas Elecsys Total prostate-
(ELI-00009) PSA specific
(FSC Germany Issuance Shelf Life: 18 Months antigen (tPSA)
Evaluator: Date 19-09-2016) Size: 100 Tests in human
Muhammad Fee Submitted Code: 04641655190 serum and
Ayub Naveed Rs. 50,000/- plasma
ii) Cobas Elecsys Total
PSA
Shelf Life: 18 Months
Size: 200 Tests
Code: 04491734190

iii) Cobas Elecsys Total

PSA
Shelf Life: 18 Months
Size: 300 Tests
Code: 07027966190

iv) Cobas Elecsys Total

PSA Calset
Shelf Life: 29 Months
Size: 4x1mL
Code: 04485220190
315. -do- Legal Manufacturer/ Accu-Chek Active The Self Approved.
Manufacturing Site: MG/DL Blood Sugar testing blood
Evaluator: M/s Roche Diagnostics Monitoring System glucose meter
Muhammad GmbH,
Ayub Naveed Sandhofer Str.116, 68305 Class C
Mannheim, Germany Shelf Life: not provided

(FSC Germany Issuance

Date 28-01-2019)
Fee Submitted
Rs. 50,000/-

316. -do- Legal Manufacturer/ Accu-Chek Active DL Blood glucose Approved.

Manufacturing Site: Blood Sugar Testing testing strips
Evaluator: M/s Roche Diagnostics Strips
Muhammad GmbH,
Ayub Naveed Sandhofer Str.116, 68305 Class C
Mannheim, Germany Shelf Life: not provided

(FSC Germany Issuance

Date
Fee Submitted
213
 Rs. 50,000/-

317. -do- Manufacturer/ Cobas® Elecsys In vitro Approved.

Manufacturing Site: Syphilis test kit qualitative
Evaluator: M/s Roche Diagnostics determination
Unum Zia GmbH, Class C of total
Shamsi Sandhofer Str.116, 68305 antibodies to
Mannheim, Germany Shelf Life: 15 Months Treponema
Pallidum in
(FSC Germany Issue (i) Cobas® Elecsys human serum
Date22-02-2018) Syphilis and plasma.
(FSC Germany Issue Size: 100 Tests The test is
Date19-09-2016) Code: 06923348 intended as an
(FSC Germany Issue aid in the
Date15-03-2018) (ii) Cobas® Elecsys diagnosis of
Fee Submitted Syphilis syphilis
Rs. 50,000/- Size: 200 Tests infection
Code: 07802960190

(iii) Cobas® Elecsys

Syphilis
Size: 300 Tests
Code: 07251378190

(iv) Cobas®
PreciControl Syphilis
Size: 4x2ml
Code: 06923364
318. -do- Manufacturer/ Cobas® Elecsys AFP Immunoassay Approved.
Manufacturing Site: test kit for the in vitro
Evaluator: M/s Roche Diagnostics quantitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of α1-
Mannheim, Germany i) Cobas® Elecsys AFP fetoprotein
Size: 100 Tests (AFP) in
(FSC Germany Issue Shelf Life: 21 Months human serum
Date 22-02-2018) Code: 04481798 and plasma.
(FSC Germany Issue
Date 19-09-2016) ii) Cobas® Elecsys AFP
(FSC Germany Issue Size: 300 Tests
Date 15-03-2017) Shelf Life: 21 Months
Code: 07026706190
Fee Submitted: Rs
50,000/- iii) Cobas® AFP CalSet
II
Size: 4x1.0mL
Shelf Life: 29 Months
Code: 04487761

iv) Cobas®
PreciControl Tumor
Marker
214
 Size: 4x3.0mL
Shelf Life: 24 Months
Code: 11776452

iv) Cobas®
PreciControl Universal
Size: 4x3.0mL
Shelf Life: 24 Months
Code: 11731416

319. -do- Legal Manufacturer/ COBAS® In vitro nucleic Approved.

Manufacturing Site: AmpliPrep/COBAS® acid
Evaluator: Roche Molecular TaqMan® HBV Test amplification
Unum Zia System Inc., 1080 US Kit, version 2.0 test for the
Shamsi Hwy quantitation of
202, South Branchburg, Class C Hepatitis B
NJ Virus (HBV)
08876, USA. Shelf Life: 25 Months DNA in
human plasma
FSC Germany Issue i) COBAS® and serum.
Date: (16-08-2018) AmpliPrep/COBAS®
TaqMan® HBV Test,
Fee Submitted: Rs version 2.0
50,000/-
Size: 72 Tests

Code: 04894570190

320. -do- Manufacturer: cobas® HBV In vitro nucleic Approved.

M/s Roche Diagnostics Quantitative nucleic acid
Evaluator: GmbH, acid test kit. amplification
Unum Zia Sandhofer Str.116, 68305 (For use on the Cobas® test for the
Shamsi Mannheim, Germany 4800 System) quantitation of
hepatitis B
Manufacturing Site: Class C virus (HBV)
Roche Molecular DNA in
System Inc.,1080 US Shelf Life: 16 Months human
Hwy 202, South EDTA plasma
Branchburg, NJ i) cobas® HBV or serum of
08876 USA. Size: 120 Tests HBV-infected
Code: 06979564190 individuals.
(FSC Germany Issue
Date15-10-2018) Fee Submitted: Rs
50,000/-

321. -do- Manufacturer: cobas® HIV-1 In vitro nucleic Approved.

M/s Roche Diagnostics Quantitative nucleic acid
Evaluator: GmbH, acid test kit amplification
Unum Zia Sandhofer Str.116, 68305 (for use on the Cobas® test for the
Shamsi Mannheim, Germany 6800/8800 Systems) quantitation of
human
Manufacturing Site: Class C immunodeficie
215
 Roche Molecular Shelf Life: 27 Months ncy virus type
System Inc.,1080 US 1
Hwy 202, South i) cobas® HIV-1 (HIV-1) in
Branchburg, NJ08876 Size: 96 Tests EDTA plasma.
USA. Code: 07000995190

(FSC Germany Issue Fee Submitted: Rs

Date 15-10-2018) 50,000/-

322. -do- Manufacturer: Cobas® HCV In vitro nucleic Approved.

M/s Roche Diagnostics Quantitative nucleic acid
Evaluator: GmbH, acid test kit amplification
Unum Zia Sandhofer Str.116, 68305 (for use on Cobas® test for both
Shamsi Mannheim, Germany 6800/8800 systems) the detection
& quantitation
Manufacturing Site: of Hepatitis C
Roche Molecular i)Cobas® HCV Virus (HCV)
System Inc.,1080 US Class C RNA
Hwy Shelf Life: 27 Months genotypes 1 to
202, South Branchburg, Size: 96 Tests 6 in human
NJ Code: 06997732190 EDTA plasma
08876 USA. or serum
ii)Cobas®
(FSC Germany Issue HBV/HCV/HIV-1
Date 15-10-2018) Control Kit
Fee submitted: Rs. Class C
50,000/- Shelf Life: 25 Months
Size: 16x0.65mL
Code: 06997767190

323. -do- Manufacturer: Cobas® HBV Invitro nucleic Approved.

M/s Roche Diagnostics Quantitative nucleic acid
Evaluator: GmbH, acid test kit amplification
Unum Zia Sandhofer Str.116, 68305 (for use on the Cobas® test for the
Shamsi Mannheim, Germany 6800/8800 Systems) quantitation of
hepatitis B
Manufacturing Site: Class C virus (HBV)
Roche Molecular DNA in
System Inc.,1080 US Shelf Life: 25 Months human
Hwy 202, South EDTA plasma
Branchburg, NJ i) Cobas® HBV or serum of
08876 USA. Size: 96 Tests HBV-infected
Code: 07000979190 individuals.
(FSC Germany Issue
Date 15-10-2018) Fee Submitted: Rs.
50,000/-

324. -do- Legal Manufacturer/ COBAS® In vitro nucleic Approved.

Manufacturing Site: AmpliPrep/COBAS® acid
Evaluator: Roche Molecular TaqMan® HIV-1 Test amplification
Unum Zia System Inc., 1080 US Kit, version 2.0 test for the
216
 Shamsi Hwy quantitation of
202, South Branchburg, Class C Human
NJ Immunodefici
08876, USA. Shelf Life: 22 Months ency Virus
Type 1 (HIV-1)
FSC Germany Issue i) COBAS® RNA in
Date: (16-08-2018) AmpliPrep/COBAS® human EDTA
TaqMan® HIV-1 Test, plasma
Fee Submitted: Rs. version 2.0
50,000/- Size: 48 Tests
Code: 05212294190

325. -do- Manufacturer: Cobas® HIV-1 In vitro nucleic Approved.

M/s Roche Diagnostics quantitative nucleic acid
Evaluator: GmbH, acid test kit amplification
Unum Zia Sandhofer Str.116, 68305 (for use on the Cobas® test for the
Shamsi Mannheim, Germany 4800 System) quantitation of
human
Class C
Manufacturing Site: immunodeficie
Roche Molecular Shelf Life: 13 Months ncy virus type
System Inc.,1080 US 1
Hwy 202, South i) Cobas® HIV-1 (HIV-1) in
Branchburg, NJ Size: 120 Tests EDTA plasma
08876 USA. Code: 06979599190 of HIV-1-
infected
(FSC Germany Issue Fee Submitted: Rs. individuals.
Date 15-10-2018) 50,000/-

326. -do- Legal Manufacturer: Cobas® HCV GT test Is an In vitro Approved.

M/s Roche Diagnostics kit nucleic acid
Evaluator: GmbH, (for use on the Cobas® amplification
Unum Zia Sandhofer Str.116, 68305 4800 System) test for the
Shamsi Mannheim, Germany qualitative
Shelf Life: 15 Months identification
Manufacturing Site: of Hepatitis C
Roche Molecular Class C virus (HCV)
System Inc.,1080 US i)Cobas® HCV GT genotypes 1
Hwy 202, South Size: 120 Tests subtypes a and
Branchburg, NJ Code: 06984274190 b in human
08876 USA. EDTA plasma
ii) Cobas® HCV GT or serum from
(FSC Germany Issue Control Kit individuals
Date 15-10- 2018) Size: 10 Sets with chronic
Fee Submitted: Rs, Code: 06984339190 HCV infection.
50,000/-

327. -do- Legal Manufacturer: Cobas® HCV In vitro nucleic Approved.

M/s Roche Diagnostics quantitative nucleic acid
Evaluator: GmbH, acid test kit amplification
Unum Zia Sandhofer Str.116, 68305 (for use on the Cobas® test for both
Shamsi Mannheim, Germany 4800 System) the detection
217
 & quantitation
Manufacturing Site: Class C of Hepatitis C
Roche Molecular Shelf Life: 15 Months Virus (HCV)
System Inc.,1080 US RNA
Hwy 202, South i) Cobas® HCV 4800 genotypes 1 to
Branchburg, NJ Size: 120 Tests 6 in human
08876 USA. Code: 06979602190 EDTA plasma
or serum.
(FSC Germany Issue ii) Cobas®
Date 15-10-2018) HBV/HCV/HIV-1
Control Kit
Fee submitted: Rs Size: 10 Tests
50,000/- Code: 06979572190

328. -do- Manufacturer/ Cobas® Elecsys CA 15- Immunologica Approved.

Manufacturing Site: 3 II test kit l in vitro assay
Evaluator: M/s Roche Diagnostics for
Unum Zia GmbH, Class C quantitative
Shamsi Sandhofer Str.116, 68305 determination
Mannheim, Germany Shelf Life: 18 Months of CA 15-3 in
human serum
(FSC Germany Issue i) Cobas® Elecsys CA and plasma to
Date 22-2-2018) 15-3 II aid in the
(FSC Germany Issue Size: 100 Tests management
Date 19-09-2016) Code: 03045838 of breast
cancer patients
Fee submitted. Rs ii) Cobas® Elecsys CA
50,000/- 15-3 II
Size: 300 Tests
Code: 07027001190

iii) Cobas® Elecsys CA

15-3 II Calset
Size: 4x1ml
Code: 03045846

329. -do- Manufacturer/ Cobas® Elecsys CEA Immunoassay Approved.

Manufacturing Site: Kit for the in vitro
Evaluator: M/s Roche Diagnostics quantitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of
Mannheim, Germany Shelf Life: 18 Months carcinoembryo
nic antigen in
(FSC Germany Issue i) Cobas® Elecsys CEA human serum
Date 19-09-2016) Size: 100 Tests and plasma
(FSC Germany Issue Code: 11731629
Date 22-02-2018)
ii) Cobas® Elecsys CEA
Fee submitted. Rs Size: 300 Tests
50,000/- Code: 07027079190
218
 iii) Cobas® Elecsys
CEA Calset
Size: 4x1ml
Code: 11731645

330. -do- Manufacturer/ Cobas® Elecsys CA 125 Immunoassay Approved.

Manufacturing Site: II test kit for the in vitro
Evaluator: M/s Roche Diagnostics quantitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of OC
Mannheim, Germany i) Cobas® Elecsys CA (Ovarian
125 II Cancer) 125
(FSC Germany Issuance Shelf Life: 18 Months reactive
Date 15-03-2017) Size: 100 Tests determinants
(FSC Germany Issuance Code: 11776223 in human
Date 22-02-2018) serum and
ii) Cobas® Elecsys CA plasma
Fees submitted: Rs. 125 II
50,000/- Shelf Life: 18 Months
Size: 300 Tests
Code: 07026986190

iii) Cobas® Elecsys CA

125 II Calset II
Shelf Life: 15 Months
Size: 4x1ml
Code: 070230207

331. -do- Manufacturer/ Cobas Elecsys Rubella Immunoassay Approved.

Manufacturing Site: IgM Test Kit for the in vitro
Evaluator: M/s Roche Diagnostics qualitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of IgM
Mannheim, Germany i) Cobas Elecsys antibodies to
Rubella IgM Rubella virus
(FSC Germany Issuance Shelf Life: 12 Months in human
Date 22-02-2018) Size: 100 Tests serum and
(FSC Germany Issuance Code: 04618831190 plasma
Date 24-10-2018)
ii) Cobas Elecsys
Rubella IgM
Shelf Life: 12 Months
Size: 300 Tests
Code: 07027796190

iii) Cobas Elecsys

Rubella IgM
PreciControl
Shelf Life: 14 Months
219
 Size: 8x1mL
Code: 04618840

Fees submitted: Rs.

50,000/-

332. -do- Legal Manufacturer/ Accu-Chek Guide Kit Self-testing Approved.

Manufacturing Site: mg/dL blood glucose
Evaluator: M/s Roche Diagnostics monitoring
Unum Zia GmbH, Class C system
Shamsi Sandhofer Str.116, 68305
Mannheim, Germany Shelf Life: N/A

(FSC Germany Issue Code: 07400870

Date 28-01-2019)
Fees submitted: Rs.
50,000/-

333. -do- Manufacturer/ Cobas Elecsys free PSA Immunoassay Approved.

Manufacturing Site: test kit for the in vitro
Evaluator: M/s Roche Diagnostics quantitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of free
Mannheim, Germany Shelf Life: 18 Months prostate-
specific
(FSC Germany Issue i) Cobas Elecsys free antigen (PSA)
Date 19-09-2016) PSA in human
(FSC Germany Issue Size: 100 Tests serum and
Date 22-02-2018) Code: 03289788 plasma

Fee submitted Rs. ii) Cobas Elecsys free

50,000/- PSA
Size: 300 Tests
Code: 07027320190

iii) Cobas Elecsys free

PSA Calset
Size: 4x1.0mL
Code: 03289796

334. -do- Manufacturer/ Cobas Elecsys CA 19-9 Immunoassay Approved.

Manufacturing Site: test kit for the in vitro
Evaluator: M/s Roche Diagnostics quantitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of CA 19-9
Mannheim, Germany i) Cobas Elecsys CA 19- tumor
9 associated
(FSC Germany Issue Shelf Life: 21 Months antigen in
Date 19-09-2016) Size: 100 Tests human serum
(FSC Germany Issue Code: 11776193 and plasma in
Date 22-02-2018) the
ii) Cobas Elecsys CA management
220
 Fee submitted: Rs. 19-9 of patient with
50,000/- Shelf Life: 21 Months cancers of the
Size: 300 Tests exocrine
Code: 07027028190 pancreas

iii) Cobas Elecsys CA

19-9 Calset
Shelf Life: 29 Months
Size: 4x1mL
Code: 11776215

335. -do- Manufacturer/ Cobas Elecsys Rubella Immunoassay Approved.

Manufacturing Site: IgG Test Kit for the in vitro
Evaluator: M/s Roche Diagnostics quantitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of IgG
Mannheim, Germany Shelf Life: 14 Months antibodies to
Rubella Virus
(FSC Germany Issue i) Cobas Elecsys in human
Date 24-10-2018) Rubella IgG serum and
(FSC Germany Issue Size: 100 Tests plasma
Date 22-02-2018) Code: 04618793190

Fee submitted: Rs. ii) Cobas Elecsys

50,000/- Rubella IgG
Size: 300 Tests
Code: 07027770190

iii) Cobas Elecsys

PreciControl Rubella
IgG
Size: 16x1mL
Code: 04618807

336. -do- Legal Manufacturer/ Accu-Chek® Instant S Self-testing Approved.

Manufacturing Site: mg/dL Set blood glucose
Evaluator: M/s Roche Diagnostics monitoring
Unum Zia GmbH, Class C system
Shamsi Sandhofer Str.116, 68305
Mannheim, Germany Shelf Life: N/A
Code: 078194470
(FSC Germany Issue
Date 30-10-2018) Fee submitted: Rs.
50,000/-

337. -do- Manufacturer/Manufact Accu-Chek® Performa Self-testing Approved.

uring Site: mg/dL Kit blood glucose
Evaluator: M/s Roche Diabetes monitoring
Unum Zia Care GmbH, Class C system
Shamsi Sandhofer Str.116, 68305
Mannheim, Germany Shelf Life: N/A

221
 (FSC Germany Issue Code: 06987788
Date 28-01-2019)
Fee submitted: Rs.
50,000/-

338. -do- Manufacturer/ Cobas® Elecsys TOXO Immunoassay Approved.

Manufacturing Site: IgG Test Kit for the in
Evaluator: M/s Roche Diagnostics vitroquantitati
Unum Zia GmbH, Class C ve
Shamsi Sandhofer Str.116, 68305 determination
Mannheim, Germany Shelf Life: 14 Months of IgG
antibodies to
(FSC Germany Issue i) Cobas® Elecsys Toxoplasma
Date 24-10-2018) TOXO IgG gondii in
(FSC Germany Issue Size: 100 Tests human serum
Date 22-02-2018) Code: 04618815190 and plasma
Fee submitted:
Rs.50,000/- ii) Cobas® Elecsys
TOXO IgG
Size: 300 Tests
Code: 07028008190

iii) Cobas® Elecsys

PreciControl TOXO IgG
Size: 16 x 1.0ml
Code: 04618823

339. -do- Manufacturer/ Cobas® Elecsys TOXO Immunoassay Approved.

Manufacturing Site: IgM Test Kit for the in vitro
Evaluator: M/s Roche Diagnostics qualitative
Unum Zia GmbH, Class C determination
Shamsi Sandhofer Str.116, 68305 of IgM
Mannheim, Germany Shelf Life: 14 Months antibodies to
Toxoplasma
i) Cobas® Elecsys gondii in
(FSC Germany Issue TOXO IgM human serum
Date 24-10-2018) Size: 100 Tests and plasma
Code: 04618858190
Fee submitted:
Rs.50,000/- ii) Cobas® Elecsys
TOXO IgM
Size: 300 Tests
Code: 07028024190

iii) Cobas® Elecsys

PreciControl TOXO
IgM
Size: 16 x 0.67ml
Code: 04618866

340. -do- Manufacturer/ Cobas® Elecsys CMV In vitro Approved.

Manufacturing Site: IgG Test Kit qualitative test
222
 Evaluator: M/s Roche Diagnostics for the
Unum Zia GmbH, Class C detection of
Shamsi Sandhofer Str.116, 68305 IgG antibodies
Mannheim, Germany i) Cobas® Elecsys CMV to CMV in
IgG human serum,
(FSC Germany Issue Shelf Life: 18 Months lithium-
Date 24-10-2018) Size: 100 Tests heparin
(FSC Germany Issue Code: 04784596190 plasma, K2-
Date 22-02-2018) EDTA plasma
ii) Cobas® Elecsys and K3-EDTA
Fee submitted: CMV IgG plasma
Rs.50,000/- Shelf Life: 18 Months
Size: 300 Tests
Code: 07027117190

iii) Cobas® Elecsys

CMV PreciControl
Shelf Life: 21 Months
Size: 16 x 1ml
Code: 04784600

341. -do- Manufacturer: Accu-Chek® Guide Intended to be Approved.

Roche Diabetes Care Test Strips used with the
Evaluator: GmbH, Accu‐Chek
Unum Zia Sandhofer Str.116, 68305 Class C Guide meter
Shamsi Mannheim, Germany to
Manufacturing Site: Shelf Life: 18 Months quantitatively
1. Roche Diabetes Care, measure
Inc. 9115 Size: 50 Tests glucose in
Hague Road, fresh capillary
Indianapolis IN Code: 07453736020 whole blood
46250, USA from the
2.Roche Operations Ltd. Fee submitted: Rs. finger,
2875 Ponce By Pass, 50,000/- palm, forearm,
Ponce PR 00732, USA and upper arm
as an aid in
(FSC Germany Issue monitoring the
Date 27-3-2019) effectiveness
of glucose
control.
342. -do- Manufacturer: Accu-Chek® Instant Intended to be Approved.
Roche Diabetes Care Test Strips used with the
Evaluator: GmbH, Accu‐Chek
Unum Zia Sandhofer Str.116, 68305 Class C Instant and
Shamsi Mannheim, Germany Accu-Chek
Manufacturing Site: Shelf Life: 18 Months Instant S
1. Roche Diabetes Care, meters
Inc. 9115 i) Accu-Chek Instant to
Hague Road, Test Strips quantitatively
Indianapolis IN Size: 10 Tests measure
46250, USA Code: 07819366020 glucose in
2.Roche Operations Ltd. ii) Accu-Chek Instant fresh capillary
223
 2875 Ponce By Pass, Test Strips whole blood
Ponce PR 00732, USA Size: 25 Tests from the
Code: 07819374020 finger,
(FSC Germany Issue iii) Accu-Chek Instant palm, forearm,
Date 27-3-2019) Test Strips and upper arm
Size: 50 Tests as an aid in
Code: 07819382020 monitoring the
effectiveness
Fee submitted: Rs. of glucose
50,000/- control.

343. -do- Manufacturer: Accu-Chek® Performa Intended to be Approved.

Roche Diabetes Care Test Strips used with the
Evaluator: GmbH, Accu-Chek
Unum Zia Sandhofer Str.116, 68305 Class C Performa and
Shamsi Mannheim, Germany Accu-Chek
Manufacturing Site: Shelf Life: 18 Months Performa
1. Roche Diabetes Care, Nano, Accu-
Inc. 9115 i) Accu-Chek Performa Chek Performa
Hague Road, Test Strips Connect,
Indianapolis IN Size: 25 Tests Accu-Chek
46250, USA Code: 06454003020 Performa
2.Roche Operations Ltd. ii) Accu-Chek Performa Expert, Accu-
2875 Ponce By Pass, Test Strips Check
Ponce PR 00732, USA Size: 50 Tests Performa
Code: 06454011020 Combo, Accu-
(FSC Germany Issue iii) Accu-Chek Chek Performa
Date 27-3-2019) Performa Test Strips insight blood
Fee submitted: Rs. Size: 100 Tests glucose meters
50,000/- Code: 06454038020 to
quantitatively
measuresgluco
se in fresh
capillary
whole blood as
an aid in the
monitoring the
effectiveness
of glucose
control
344. -do- Manufacturer: Accu-Chek® Inform II Intended to be Approved.
Roche Diabetes Care Test Strips used with the
Evaluator: GmbH, Accu Chek
Unum Zia Sandhofer Str.116, 68305 Class C Inform II,
Shamsi Mannheim, Germany Accu Chek
Manufacturing Site: Shelf Life: 18 Months Performa and
1. Roche Diabetes Care, Accu Chek
Inc. 9115 Size: Performa
Hague Road, 50 tests Nano blood
Indianapolis IN glucose meters
46250, USA Code: to
224
 2.Roche Operations Ltd. 05942861022 quantitatively
2875 Ponce By Pass, measures
Ponce PR 00732, USA Fee submitted: Rs. glucose in
50,000/- fresh venous,
(FSC Germany Issue neonatal,
Date 27-3-2019) arterial and
capillary
whole blood
from the finger
as an aid in the
monitoring the
effectiveness
of glucose
control
345. M/s Abbott Legal Manufacturer/ Alinity I Rubella IgM IVD Kit used Approved.
Laboratories Manufacturing Site: Kit for the
(Pakistan) Ltd, M/s Abbott Ireland qualitative
Opposite Radio Diagnostics Division Class C detection of
Pakistan Finisklin Business Park IgM
Transmission Sligo, Ireland i) Alinity I Rubella IgM antibodies to
Center, Reagent Kit Rubella virus
Hyderabad (FSC Ireland Valid Till Code: 08P4722 in human
Road, Landhi, 26-05-2022) Shelf Life: 12 Months serum and
Karachi plasma
Fee submitted: Rs.
(ELI-00019) 50,000/- ii) Alinity I Rubella IgM
Reagent Kit
Evaluator: Code: 08P4732
Muhammad Shelf Life: 12 Months
Ayub Naveed
iii) Alinity I Rubella
IgM Calibrator
Code: 08P4701
Shelf Life: 12 Months

iv) Alinity I Rubella

IgM Controls
Code: 08P4710
Shelf Life: 12 Months
346. -do- Legal Manufacturer/ SD HBsAg ELISA 3.0 In-Vitro Approved
Manufacturing Site: (01EK10) Diagnostic Kit subject to
Evaluator: M/s Standard 96 Tests /Kit for HBsAg foreign
Muhammad Diagnostics, Inc. 65, Testing inspection
Ayub Naveed Borahagai-ro, Giheung- Class D abroad. The
gu, Yongin-si, Gyeonggi- Board also
do, Korea Shelf Life: 12 Months authorized
the Secretary
(FSC Republic of Korea MDB to issue
Issue date 11-08-2017) registration
Fee submitted: Rs. of product if
50,000/- the
manufacturin
225
 g plant is
approved by
the panel of
experts.

347. -do- Legal Manufacturer/ SD BIOLINE Anti-HBs In-Vitro Approved

Manufacturing Site: Diagnostic Kit subject to
Evaluator: M/s Standard Class D for Anti-HBs foreign
Muhammad Diagnostics, Inc. 65, Testing inspection
Ayub Naveed Borahagai-ro, Giheung- (1)SD BIOLINE Anti- abroad. The
gu, Yongin-si, Gyeonggi- HBs Board also
do, Korea 01FK20 (30 Test/Kit) authorized
Shelf Life: 24 Months the Secretary
(FSC Republic of Korea MDB to issue
Issue date 11-08-2017) (2)SD BIOLINE Anti- registration
HBs (Multi) of product if
Fee submitted: Rs. 01FK21 (100 Test/Kit) the
50,000/- Shelf Life: 24 Months manufacturin
g plant is
Fee Submitted: approved by
Rs.50,000/- the panel of
experts.

348. -do- Legal Manufacturer/ SD BIOLINE HBsAg IVD Reagents Approved

Manufacturing Site: for serotyping subject to
Evaluator: M/s Standard SD BIOLINE HBsAg or patient foreign
Muhammad Diagnostics, Inc. 65, (01FK10) (30 Test/Kits) monitoring of inspection
Ayub Naveed Borahagai-ro, Giheung- HIV, HBV, abroad. The
gu, Yongin-si, Gyeonggi- SD BIOLINE HBsAg HCV, HTLV, Board also
do, Korea (Multi) (01FK11) (100 Immunologica authorized
Test/Kit) l method the Secretary
(FSC Republic of Korea MDB to issue
Issue date 11-08-2017) Class D registration
of product if
Fee submitted: Rs. Shelf Life: 24 Months the
50,000/- manufacturin
g plant is
approved by
the panel of
experts.

349. -do- Legal Manufacturer/ HIV 1/2 Human HIV 1/2 Approved
Manufacturing Site: Immunodeficiency Human subject to
Evaluator: M/s Abon Biopharm Virus Rapid Test Strip Immunodefici foreign
Muhammad (Hangzhou) Co., Ltd., (Whole ency Virus inspection
Ayub Naveed No. 198 12th Street East, Blood/Serum/Plasma) Rapid Test abroad. The
Hangzhou Economic & IHI-401 (Strip:50 Strip Board also
Technological Test/Kit) 20163400002 authorized
Development Area, the Secretary
Hangzhou, 310018, P.R. Class D MDB to issue
China registration
Shelf Life: 25 Months of product if
226
 (FSC China Valid Till the
04-06-2019) manufacturin
Fee submitted: Rs. g plant is
50,000/- approved by
the panel of
experts.

350. -do- Legal Manufacturer/ ARCHITECT CMV IgM IVD Kit for the Approved.
Manufacturing Site: qualitative
Evaluator: M/s Abbott Ireland Class C detection of
Muhammad Diagnostics Division IgM antibodies
Ayub Naveed Finisklin Business Park i) ARCHITECT CMV to
Sligo, Ireland IgM Calibrators Cytomegalovir
Code: 6C16-01 us in human
(FSC Ireland Valid Till Shelf Life: 12 Months serum and
26-05-2022) plasma
Fee submitted: Rs. ii) ARCHITECT CMV
50,000/- IgM Controls
Code: 6C16-10
Shelf Life: 12 Months

iii) ARCHITECT CMV

IgM Reagent
(1 x 100 Tests)
Code: 6C16-25
Shelf Life: 12 Months

iv) ARCHITECT CMV

IgM Reagent
(1 x 500 Tests)
Code: 6C16-30
Shelf Life: 12 Months

351. -do- Legal Manufacturer/ ARCHITECT AFP IVD Kit for the Approved.
Manufacturing Site: quantitative
Evaluator: M/s Abbott Ireland Class C determination
Muhammad Diagnostics Division of alpha-
Ayub Naveed Finisklin Business Park i) ARCHITECT AFP fetoprotein in
Sligo, Ireland Calibrators human serum
Code: 3P36-01 and plasma
(FSC Ireland Valid Till Shelf Life: 12 Months
26-05-2022)
Fee submitted: Rs. ii) ARCHITECT AFP
50,000/- Controls
Code: 3P36-10
Shelf Life: 12 Months

iii) ARCHITECT AFP

Reagent
Code: 3P36-20
227
 Shelf Life: 12 Months

iv) ARCHITECT AFP

Reagent
Code: 3P36-25
Shelf Life: 12 Months

v) ARCHITECT AFP
Reagent
Code: 3P36-30
Shelf Life: 12 Months

vi) ARCHITECT AFP

Reagent
Code: 3P36-35
Shelf Life: 12 Months
352. -do- Legal Manufacturer/ ARCHITECT Total PSA IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott Ireland Class C quantitative
Muhammad Diagnostics Division determination
Ayub Naveed Finisklin Business Park i) ARCHITECT Total of Total PSA
Sligo, Ireland PSA Reagent (both Free PSA
Code: 7K70-20 and PSA
(FSC Ireland Valid Till Shelf Life: 12 Months complexed to
26-05-2022) alpha-1-
Fee submitted: Rs. ii) ARCHITECT Total antichymotryp
50,000/- PSA Reagent sin) in human
Code: 7K70-25 serum
Shelf Life: 12 Months

iii) ARCHITECT Total

PSA Reagent
Code: 7K70-30
Shelf Life: 12 Months

iv) ARCHITECT Total

PSA Reagent
Code: 7K70-35
Shelf Life: 12 Months

v) ARCHITECT Total
PSA Calibrators
Code: 7K70-01
Shelf Life: 12 Months

vi) ARCHITECT Total

PSA Controls
Code: 7K70-10
Shelf Life: 12 Months
353. -do- Legal Manufacturer/ ARCHITECT CMV IgG IVD Kit used Approved.
Manufacturing Site: Avidity for the
Evaluator: M/s Abbott Ireland determination
228
 Muhammad Diagnostics Division Class C of the avidity
Ayub Naveed Finisklin Business Park of IgG
Sligo, Ireland i) ARCHITECT CMV antibodies to
IgG Avidity Calibrator Cytomegalovir
(FSC Ireland Valid Till and Controls us in human
26-05-2022) Code: 3L46-11 serum and
Fee submitted: Rs. Shelf Life: 12 Months plasma
50,000/-
ii) ARCHITECT CMV
IgG Avidity Reagent
Code: 3L46-25 (100
Tests)
Shelf Life: 12 Months
354. -do- Legal Manufacturer/ Abbott Real Time High In-Vitro Approved.
Manufacturing Site: Risk HPV Diagnostic Kit
Evaluator: M/s Abbott GmbH & for Human
Muhammad Co. KG Max-Planck-Ring Class C papillomaviru
Ayub Naveed 2, 65205 Wiesbaden, s (HPV)
Germany i) Abbott Real Time Testing
High Risk HPV Control
(FSC Germany Issuance Kit
Date 26-01-2016) Code: 2N09-80
Fee submitted: Rs. Shelf Life: 18 Months
50,000/-
ii) Abbott Real Time
High Risk HPV
Amplification Reagent
Kit
Code: 2N09-90
Shelf Life: 18 Months
355. -do- Legal Manufacturer/ Abbott Real Time MTB MTB (Real Approved.
Manufacturing Site: Time PCR)
Evaluator: M/s Abbott GmbH & Class C
Muhammad Co. KG Max-Planck-Ring
Ayub Naveed 2, 65205 Wiesbaden, i) Abbott Real Time
Germany MTB Control Kit
Code: 08N15-080
(FSC Germany Issuance Shelf Life: 18 Months
Date 26-01-2016)
Fee submitted: Rs. iii) Abbott Real Time
50,000/- MTB Amplification
Reagent Kit
Code: 08N15-090 (96
Tests)
Shelf Life: 18 Months
356. -do- Legal Manufacturer/ Abbott RealTime MTB In-Vitro Approved.
Manufacturing Site: RIF/INH Resistance Diagnostic Kit
Evaluator: M/s Abbott Molecular, Amplification Kit for RealTime
Muhammad Inc. 1300 East Touhy PCR Testing of
Ayub Naveed Avenue Des Plaines, IL, Class C MTB
600180 USA
i) Abbott RealTime
229
 M/s Abbott GmbH & MTB RIF/INH
Co. KG Max-Planck-Ring Resistance Control Kit
2, 65205 Wiesbaden, Code: 08N28-080
Germany Shelf Life: 18 Months

(FSC USFDA Valid Till ii) Abbott RealTime

10-05-2020) MTB RIF/INH
Resistance
(FSC Germany Issuance Amplification Reagent
Date 28-01-2016) Kit
Fee submitted: Rs. Code: 08N28-090
50,000/- Shelf Life: 18 Months

357. -do- Legal Manufacturer/ Alinity i STAT High IN-VITRO Approved.

Manufacturing Site: Sensitive Troponin-I DIAGNOSTIC
Evaluator: M/s Abbott Ireland Kit for Alinity
Muhammad Diagnostic Division, Class C i STAT High
Ayub Naveed Lisnamuck, Longford, Sensitive
(i) Alinity i STAT High
Co. Longford, Ireland Troponin-I
Sensitive Troponin-I
Testing
Reagent Kit
(FSC Ireland Valid Till
Code: 08P1322
29-03-2023)
Shelf Life: 06 Months

(ii) Alinity i STAT High

Sensitive Troponin-I
Reagent Kit
Code: 08P1332
Shelf Life: 06 Months

(iii) Alinity i STAT

High Sensitive
Troponin-I Calibrators
Code: 08P1301
Shelf Life: 09 Months

(iv) Alinity i STAT

High Sensitive
Troponin-I Controls
Code: 08P1310
Shelf Life: 06 Months

358. -do- Legal Manufacturer: Abbott RealTime HIV-1 IN-VITRO Approved.

M/s Abbott GmbH & DIAGNOSTIC
Evaluator: Co. KG Max-Planck-Ring Class C Kit for Abbott
Muhammad 2 65205 Wiesbaden, RealTime HIV-
(i) Abbott RealTime
Ayub Naveed Germany 1
HIV-1 Amplification
Testing
Reagent Kit
Manufacturing Site:
Code: 02G31-90
M/s Abbott Molecular
Shelf Life: 18Months
Inc. 1300E. Touhy Ave.
Des Plaines, II 60018,
(ii) Abbott RealTime
230
 USA HIV-1 Control Kit
Code: 02G31-80
(FSC Germany Issuance Shelf Life: 18Months
Date 28-01-2016)
(iii) Abbott RealTime
HIV-1 Control Kit
Rs.50,000/- Code: 02G31-70
Fee already submitted Shelf Life: 18Months
against Slip No. 0580488
dated 22-11-2016

359. -do- Manufacturer/Distribut Free Style Optium NEO Glucose and Approved.
or: Blood Glucose and Ketone
Evaluator: M/s Abbott Diabetes Ketone Monitoring Monitoring
Muhammad Care Ltd, Range Road, System System
Ayub Naveed Witney, Oxon, OX29
0YL, UK Class C

(FSC UK Issuance Date Shelf Life: Not

10-04-2018) Applicable
Fee submitted: Rs.
50,000/-

360. do- Manufacturer/Distribut Free Style Optium NEO Glucose and Approved.
or: H Blood Glucose and Ketone
Evaluator: M/s Abbott Diabetes Ketone Monitoring Monitoring
Muhammad Care Ltd, Range Road, System System
Ayub Naveed Witney, Oxon, OX29
0YL, UK Class C

(FSC UK Issuance Date Shelf Life: Not

10-04-2018) Applicable
Fee submitted: Rs.
50,000/-

361. -do- Legal Manufacturer/ SD BIOLINE Malaria In-Vitro Approved

Manufacturing Site: Ag P.f/P.v Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Malaria foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE Malaria Board also
do, Republic of Korea. Ag P.f/P.v authorized
05FK80 (25 Test/Kit) the Secretary
(FSC Korea Dated11-08- (2)SD BIOLINE Malaria MDB to issue
2017) Ag P.f/P.v registration
Fee Submitted: 05FK83 (1 test/kit x 25 of product if
Rs.50,000/- each) the
Shelf Life: 24 Months manufacturin
g plant is
approved by
the panel of
experts.
231
362. -do- Legal Manufacturer/ SD BIOLINE Dengue In-Vitro Approved
Manufacturing Site: IgG/IgM Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Dengue foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE Dengue Board also
do, Republic of Korea. IgG/IgM authorized
11FK10 (25 Test/Kit) the Secretary
(FSC Korea Dated 11-08- MDB to issue
2017) Shelf Life: 24 Months registration
of product if
Fee Submitted: the
Rs.50,000/- manufacturin
g plant is
approved by
the panel of
experts.

363. -do- Legal Manufacturer/ SD BIOLINE TB Ag In-Vitro Approved

Manufacturing Site: MPT64 Rapid Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Detection foreign
Unum Zia Diagnostics Inc.,65, Class C of M. inspection
Shamsi Borahagal-ro, Giheung- Tuberculosis abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE TB Ag Complex Board also
do, Republic of Korea. MPT64 Rapid authorized
08FK50 (25 Test/Kit) the Secretary
(FSC Korea Dated 11-08- MDB to issue
2017) Shelf Life: 18 Months registration
of product if
Fee Submitted: the
Rs.50,000/- manufacturin
g plant is
approved by
the panel of
experts.

364. -do- Legal Manufacturer/ SD BIOLINE Troponin I In-Vitro Approved

Manufacturing Site: Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Troponin I foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- (cardiac abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE marker) Board also
do, Republic of Korea. Troponin I authorized
90FK10 (25 Test/Kit) the Secretary
(FSC Korea Dated 18-08- MDB to issue
2018) Shelf Life: 24 Months registration
of product if
Fee Submitted: the
Rs.50,000/- manufacturin
g plant is
approved by
232
 the panel of
experts.

365. -do- Legal Manufacturer/ SD BIOLINE Malaria In-Vitro Approved

Manufacturing Site: Ag P.f/Pan Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Malaria foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE Malaria Board also
do, Republic of Korea. Ag P.f/Pan authorized
05FK60 (25 Test/Kit) the Secretary
(FSC Korea Dated 11-08- (2)SD BIOLINE Malaria MDB to issue
2017 Ag P.f/Pan registration
WHO-PreQualified) 05FK63 (1 test/kit x of product if
25each) the
Shelf Life: 24 Months manufacturin
g plant is
Fee Submitted: approved by
Rs.50,000/- the panel of
experts.

366. -do- Legal Manufacturer/ SD BIOLINE Dengue In-Vitro Approved

Manufacturing Site: IgG/IgM,WB Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Dengue foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE Dengue Board also
do, Republic of Korea. IgG/IgM,WB authorized
11FK20 (25 Test/Kit) the Secretary
(FSC Korea Dated 11-08- MDB to issue
2017) Shelf Life: 24 Months registration
of product if
Fee Submitted: the
Rs.50,000/- manufacturin
g plant is
approved by
the panel of
experts.

367. -do- Legal Manufacturer/ SD BIOLINE Syphilis In-Vitro Approved

Manufacturing Site: 3.0 Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Syphilis foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE Syphilis Board also
do, Republic of Korea. 3.0 authorized
06FK10 (30 Test/Kit) the Secretary
(FSC Korea Dated 11-08- (2)SD BIOLINE Syphilis MDB to issue
2017) 3.0 registration
06FK11 (Multi) (100 of product if
Test/Kit) the
Shelf Life: 24 Months manufacturin
233
 g plant is
Fee Submitted: approved by
Rs.50,000/- the panel of
experts.

368. -do- Legal Manufacturer/ SD BIOLINE Dengue In-Vitro Approved

Manufacturing Site: Duo Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Dengue foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE Dengue Board also
do, Republic of Korea. Duo authorized
11FK45 (10 Test/Kit) the Secretary
(FSC Korea Dated 11-08- (2) SD BIOLINE MDB to issue
2017) Dengue Duo registration
11FK46 (25 Test/Kit) of product if
Shelf Life: 24 Months the
manufacturin
Fee Submitted: g plant is
Rs.50,000/- approved by
the panel of
experts.

369. -do- Legal Manufacturer/ SD BIOLINE Dengue In-Vitro Approved

Manufacturing Site: NS1 Ag Test Kit Diagnostic Kit subject to
Evaluator: M/s Standard for Dengue foreign
Unum Zia Diagnostics Inc.,65, Class C Testing inspection
Shamsi Borahagal-ro, Giheung- abroad. The
gu, Yongin-si, Gyeonggi- (1)SD BIOLINE Dengue Board also
do, Republic of Korea. NS1 Ag authorized
11FK50 (25 Test/Kit) the Secretary
(FSC Korea Dated 11-08- MDB to issue
2017) Shelf Life: 24 Months registration
of product if
Fee Submitted: the
Rs.50,000/- manufacturin
g plant is
approved by
the panel of
experts.

370. M/s Abbott Legal Manufacturer/ ARCHITECT CEA IVD Kit for the Approved.
Laboratories Manufacturing Site: quantitative
(Pakistan) Ltd, M/s Abbott Ireland Class C determination
Opposite Radio Diagnostics Division of
Pakistan Finisklin Business Park i) ARCHITECT CEA Carcinoembry
Transmission Sligo, Ireland Reagent onic Antigen
Center, Code: 7K68-22 (CEA) in
Hyderabad (FSC Ireland Valid Till Shelf Life: 18 Months human serum
Road, Landhi, 26-05-2022) and plasma
Karachi ii) ARCHITECT CEA
Reagent
234
 (ELI-00019) Code: 7K68-27
Shelf Life: 18 Months

iii) ARCHITECT CEA

Reagent
Code: 7K68-32
Shelf Life: 18 Months

iv) ARCHITECT CEA

Reagent
Code: 7K68-35
Shelf Life: 18 Months

v) ARCHITECT CEA
Calibrators
Code: 7K68-02
Shelf Life: 26 Months

vi) ARCHITECT CEA

Controls
Code: 7K68-12
Shelf Life: 26 Months
371. -do- Legal Manufacturer/ ARCHITECT Free PSA IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott Ireland Class C quantitative
Hafiz Diagnostics Division determination
Muhammad Asif Finisklin Business Park i) ARCHITECT Free of
Iqbal Sligo, Ireland PSA Calibrators free prostate
Code: 7K71-01 specific
(FSC Ireland Valid Till Shelf Life: 12 Months antigen (PSA)
26-05-2022) in human
Fee submitted: Rs. ii) ARCHITECT Free serum
50,000/- PSA Controls
Code: 7K71-10
Shelf Life: 12 Months

iii) ARCHITECT Free

PSA Reagent
Code: 7K71-20
Shelf Life: 12 Months

iv) ARCHITECT Free

PSA Reagent
Code: 7K71-25
Shelf Life: 12 Months

372. -do- Legal Manufacturer/ ARCHITECT IVD Kit used Approved.

Manufacturing Site: Methotrexate for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C determination
Muhammad Asif 2, 65205 Wiesbaden, of
235
 Iqbal Germany i) ARCHITECT methotrexate
Methotrexate in
(FSC Germany Issuance Calibrators human serum
Date 19-07-2018) Code: 2P49-01 and plasma
Shelf Life: 18 Months
Fee submitted: Rs.
50,000/- ii) ARCHITECT
Methotrexate Controls
Code: 2P49-10
Shelf Life: 18 Months

iii) ARCHITECT
Methotrexate Extended
Range Controls
Code: 2P49-15
Shelf Life: 18 Months

iv) ARCHITECT
Methotrexate Reagent
Kit
Code: 2P49-25
Shelf Life: 18 Months

373. -do- Legal Manufacturer/ ARCHITECT HE4 IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) ARCHITECT HE4 of HE4 antigen
Iqbal Germany Calibrators in human
Code: 2P54-01 serum
(FSC Germany Issuance Shelf Life: 12 Months
Date 19-07-2018)
Fee submitted: Rs. ii) ARCHITECT HE4
50,000/- Controls
Code: 2P54-10
Shelf Life: 12 Months

iii) ARCHITECT HE4

Reagent Kit
Code: 2P54-25
Shelf Life: 12 Months

374. -do- Legal Manufacturer/ ARCHITECT HAV Ab- IVD Kit used Approved.
Manufacturing Site: IgG for the
Evaluator: M/s Abbott GmbH & qualitative
Hafiz Co. KG Max-Planck-Ring Class C detection of
Muhammad Asif 2, 65205 Wiesbaden, IgG antibody
Iqbal Germany i) ARCHITECT HAV to hepatitis A
Ab-IgG Calibrators virus (IgG
(FSC Germany Issuance Code: 6C29-01 anti-HAV) in
Date 19-07-2018) Shelf Life: 12 Months human serum
236
 and
Fee submitted: Rs. ii) ARCHITECT HAV plasma
50,000/- Ab-IgG Controls
Code: 6C29-10
Shelf Life: 12 Months

iii) ARCHITECT HAV

Ab-IgG Reagent Kit
(4x100 Tests)
Code: 6C29-22
Shelf Life: 12 Months

iv) ARCHITECT HAV

Ab-IgG Reagent Kit
(1x100 Tests)
Code: 6C29-27
Shelf Life: 12 Months

375. -do- Legal Manufacturer/ ARCHITECT IVD Kit used Approved.

Manufacturing Site: iGentamicin for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C determination
Muhammad Asif 2, 65205 Wiesbaden, of gentamicin,
Iqbal Germany i) ARCHITECT an antibiotic
iGentamicin Calibrators drug,
(FSC Germany Issuance Code: 1P31-01 in human
Date 19-07-2018) Shelf Life: 12 Months serum or
Fee submitted: Rs. plasma
50,000/- ii) ARCHITECT
iGentamicin Reagent
Kit
Code: 1P31-25
Shelf Life: 12 Months

376. -do- Legal Manufacturer/ ARCHITECT Toxo IgG IVD Kit used Approved.
Manufacturing Site: Avidity for the
Evaluator: M/s Abbott GmbH & determination
Hafiz Co. KG Max-Planck-Ring Class C of the avidity
Muhammad Asif 2, 65205 Wiesbaden, of IgG
Iqbal Germany i) ARCHITECT Toxo antibodies to
IgG Avidity Calibrator Toxoplasma
(FSC Germany Issuance & Controls gondii in
Date 19-07-2018) Code: 6L37-11 human serum
Fee submitted: Rs. Shelf Life: 12 Months and plasma
50,000/-
ii) ARCHITECT Toxo
IgG Avidity Reagent
Kit
Code: 6L37-25
Shelf Life: 12 Months

377. -do- Legal Manufacturer/ ARCHITECT EBV VCA IVD Kit used Approved.
237
 Manufacturing Site: IgM for the
Evaluator: M/s Abbott GmbH & qualitative
Hafiz Co. KG Max-Planck-Ring Class C detection of
Muhammad Asif 2, 65205 Wiesbaden, i) ARCHITECT EBV IgM antibodies
Iqbal Germany VCA IgM Calibrator to
Code: 3P66-01 Epstein-Barr
(FSC Germany Issuance Shelf Life: 18 Months Virus (EBV)
Date 19-07-2018) Viral Capsid
ii) ARCHITECT EBV Antigen (VCA)
Fee submitted: Rs. VCA IgM Controls in human
50,000/- Code: 3P66-10 serum and
Shelf Life: 18 Months plasma
iii) ARCHITECT EBV
VCA IgM Reagent Kit
(1x100 Tests)
Code: 3P66-25
Shelf Life: 18 Months
iv) ARCHITECT EBV
VCA IgM Reagent Kit
(1x500 Tests)
Code: 3P66-35
Shelf Life: 18 Months

378. -do- Legal Manufacturer/ ARCHITECT IVD Kit used Approved.

Manufacturing Site: iVancomycin for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C measurement
Muhammad Asif 2, 65205 Wiesbaden, of vancomycin
Iqbal Germany i) ARCHITECT in human
iVancomycin Calibrator serum or
(FSC Germany Issuance Code: 1P30-01 plasma
Date 19-07-2018) Shelf Life: 12 Months
Fee submitted: Rs.
50,000/- ii) ARCHITECT
iVancomycin Reagent
Kit (1x100 Tests)
Code: 1P30-27
Shelf Life: 18 Months

379. -do- Legal Manufacturer/ ARCHITECT HAV Ab- IVD Kit used Approved.
Manufacturing Site: IgM for the
Evaluator: M/s Abbott GmbH & qualitative
Hafiz Co. KG Max-Planck-Ring Class C detection of
Muhammad Asif 2, 65205 Wiesbaden, IgM antibody
Iqbal Germany i) ARCHITECT HAV to hepatitis A
Ab-IgM Calibrator virus (IgM
(FSC Germany Issuance Code: 6C30-22 anti-HAV) in
Date 19-07-2018)3 Shelf Life: 12 Months human serum
and
Fee submitted: Rs. ii) ARCHITECT HAV plasma.
50,000/- Ab-IgM Controls
238
 Code: 6C30-11
Shelf Life: 12 Months

iii) ARCHITECT HAV

Ab-IgM Reagent Kit
(4x100 Tests)
Code: 6C30-22
Shelf Life: 12 Months

iv) ARCHITECT HAV

Ab-IgM Reagent Kit
(1x100 Tests)
Code: 6C30-27
Shelf Life: 12 Months

380. -do- Legal Manufacturer/ ARCHITECT CYFRA IVD Kit used Approved.
Manufacturing Site: 21-1 for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C determination
Muhammad Asif 2, 65205 Wiesbaden, of human
Iqbal Germany i) ARCHITECT CYFRA cytokeratin 19
21-1 Calibrator fragments in
(FSC Germany Issuance Code: 2P55-01 human serum
Date 19-07-2018) Shelf Life: 12 Months and plasma
Fee submitted: Rs.
50,000/- ii) ARCHITECT CYFRA
21-1 Controls
Code: 2P55-10
Shelf Life: 12 Months

iii) ARCHITECT
CYFRA 21-1 Reagent
Kit
Code: 2P55-25
Shelf Life: 12 Months

381. -do- Legal Manufacturer/ ARCHITECT CA 15-3 IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) ARCHITECT CA 15-3 of DF3 defined
Iqbal Germany Reagent Kit antigen in
Code: 2K44-21 human serum
(FSC Germany Issuance Shelf Life: 12 Months and plasma
Date 30-10-2017)
ii) ARCHITECT CA 15-
Fee submitted: Rs. 3 Reagent Kit
50,000/- Code: 2K44-27
Shelf Life: 12 Months

iii) ARCHITECT CA 15-

3 Reagent Kit
239
 Code: 2K44-37
Shelf Life: 12 Months

iv) ARCHITECT CA 15-

3 Calibrators
Code: 2K44-02
Shelf Life: 12 Months

v) ARCHITECT CA 15-
3 Controls
Code: 2K44-11
Shelf Life: 12 Months

382. -do- Legal Manufacturer/ ARCHITECT EBV IVD Kit used Approved.
Manufacturing Site: EBNA-1 IgG for the
Evaluator: M/s Abbott GmbH & qualitative
Hafiz Co. KG Max-Planck-Ring Class C detection of
Muhammad Asif 2, 65205 Wiesbaden, IgG antibodies
Iqbal Germany i) ARCHITECT EBV to Epstein-Barr
EBNA-1 IgG Calibrator Nuclear
(FSC Germany Issuance Code: 3P67-01 Antigen-1
Date 19-07-2018) Shelf Life: 18 Months (EBNA-1) in
human serum
Fee submitted: Rs. ii) ARCHITECT EBV and plasma
50,000/- EBNA-1 IgG Controls
Code: 3P67-10
Shelf Life: 18 Months

iii) ARCHITECT EBV

EBNA-1 IgG Reagent
Kit (1x100 Tests)
Code: 3P67-25
Shelf Life: 18 Months

iv) ARCHITECT EBV

EBNA-1 IgG Reagent
Kit (1x500 Tests)
Code: 3P67-35
Shelf Life: 18 Months

383. -do- Legal Manufacturer/ ARCHITECT Galectin-3 IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) ARCHITECT of galectin-3 in
Iqbal Germany Galectin-3 Calibrator human serum
Code: 5P03-01 and EDTA
(FSC Germany Issuance Shelf Life: 18 Months plasma.
Date 19-07-2018)
ii) ARCHITECT
Fee submitted: Rs. Galectin-3 Controls
50,000/- Code: 5P03-10
240
 Shelf Life: 18 Months

iii) ARCHITECT
Galectin-3 Reagent Kit
(100 test)
Code: 5P03-25
Shelf Life: 18 Months

384. -do- Legal Manufacturer/ ARCHITECT EBV VCA IVD Kit used Approved.
Manufacturing Site: IgG for the
Evaluator: M/s Abbott GmbH & qualitative
Hafiz Co. KG Max-Planck-Ring Class C detection of
Muhammad Asif 2, 65205 Wiesbaden, IgG antibodies
Iqbal Germany i) ARCHITECT EBV to
VCA IgG Calibrator Epstein-Barr
(FSC Germany Issuance Code: 3P-65-01 Virus (EBV)
Date 19-07-2018) Shelf Life: 18 Months Viral Capsid
Fee submitted: Rs. Antigen (VCA)
50,000/- ii) ARCHITECT EBV in human
VCA IgG Controls serum and
Code: 3P-65-10 plasma
Shelf Life: 18 Months
iii) ARCHITECT EBV
VCA IgG Reagent Kit
(1x100 Tests)
Code: 3P-65-25
Shelf Life: 18 Months

iv) ARCHITECT EBV

VCA IgG Reagent Kit
(1x500 Tests)
Code: 3P-65-35
Shelf Life: 18 Months

385. -do- Legal Manufacturer/ ARCHITECT Toxo IgG IVD Kit for the Approved.
Manufacturing Site: quantitative
Evaluator: M/s Abbott GmbH & Class C determination
Hafiz Co. KG Max-Planck-Ring of IgG
Muhammad Asif 2, 65205 Wiesbaden, i) ARCHITECT Toxo antibodies to
Iqbal Germany IgG Calibrator Toxoplasma
Code: 6C19-01 gondii in
(FSC Germany Issuance Shelf Life: 12 Months human serum
Date 19-07-2018) and plasma
ii) ARCHITECT Toxo
Fee submitted: Rs. IgG Controls
50,000/- Code: 6C19-10
Shelf Life: 12 Months

iii) ARCHITECT Toxo

IgG Reagent Kit (1x100
Tests)
Code: 6C19-25
241
 Shelf Life: 12 Months

iv) ARCHITECT Toxo

IgG Reagent Kit (1x500
Tests)
Code: 6C19-35
Shelf Life: 12 Months

386. -do- Legal Manufacturer/ Alinity I CA 19-9 XR IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) Alinity I CA 19-9 XR of
Iqbal Germany Calibrator 1116-NS-19-9
Code: 08P3201 reactive
(FSC Germany Issuance Shelf Life: 12 Months determinants
Date 19-07-2018) in human
ii) Alinity I CA 19-9 XR serum or
Fee submitted: Rs. Controls plasma
50,000/- Code: 08P3210
Shelf Life: 12 Months

iii) Alinity I CA 19-9 XR

Reagent Kit (2x100
Tests)
Code: 08P3220
Shelf Life: 12 Months

iv) Alinity I CA 19-9 XR

Reagent Kit (2x500
Tests)
Code: 08P3230
Shelf Life: 12 Months

387. -do- Legal Manufacturer/ Alinity I BNP IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) Alinity I BNP of
Iqbal Germany Calibrators human B-type
Code: 08P2401 natriuretic
(FSC Germany Issuance Shelf Life: 12 Months peptide (BNP)
Date 26-01-2016) in human
ii) Alinity I BNP EDTA plasma
Fee submitted: Rs. Controls
50,000/- Code: 08P2410
Shelf Life: 12 Months

iii) Alinity I BNP

Reagent Kit (2x100
Tests)
Code: 08P2420
242
 Shelf Life: 12 Months

iv) Alinity I BNP

Reagent Kit (2x500
Tests)
Code: 08P2430
Shelf Life: 12 Months

388. -do- Legal Manufacturer/ ARCHITECT IVD Kit used Approved.

Manufacturing Site: iCarbamazepine for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C measurement
Muhammad Asif 2, 65205 Wiesbaden, of
Iqbal Germany i) ARCHITECT carbamazepine
iCarbamazepine , an
(FSC Germany Issuance Calibrators anticonvulsant
Date 26-01-2016) Code: 1P36-01 drug, in
Shelf Life: 12 Months human serum
Fee submitted: Rs. or plasma
50,000/- ii) ARCHITECT
iCarbamazepine
Reagent Kit
Code: 1P36-25
Shelf Life: 12 Months

389. -do- Legal Manufacturer/ ARCHITECT IVD Kit used Approved.

Manufacturing Site: iTheophylline for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C measurement
Muhammad Asif 2, 65205 Wiesbaden, of theophylline
Iqbal Germany i) ARCHITECT in human
iTheophylline serum or
(FSC Germany Issuance Calibrators plasma
Date 19-07-2018) Code: 1P29-01
Shelf Life: 18 Months
Fee submitted: Rs.
50,000/- ii) ARCHITECT
iTheophylline Reagent
Kit
Code: 1P29-01
Shelf Life: 18 Months

390. -do- Legal Manufacturer/ ARCHITECT BNP IVD Kit for the Approved.
Manufacturing Site: quantitative
Evaluator: M/s Abbott GmbH & Class C determination
Hafiz Co. KG Max-Planck-Ring of human B-
Muhammad Asif 2, 65205 Wiesbaden, i) ARCHITECT BNP type
Iqbal Germany Reagent Kit natriuretic
Code: 8K28-28 peptide (BNP)
(FSC Germany Issuance Shelf Life: 12 Months in human
Date 30-10-2017) EDTA plasma
Fee submitted: Rs. ii) ARCHITECT BNP
243
 50,000/- Reagent Kit
Code: 8K28-36
Shelf Life: 12 Months

iii) ARCHITECT BNP

Calibrators
Code: 8K28-03
Shelf Life: 12 Months

iv) ARCHITECT BNP

Controls
Code: 8K28-12
Shelf Life: 12 Months

391. -do- Legal Manufacturer/ ARCHITECT i Toxo IVD Kit used Approved.
Manufacturing Site: IgG for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C determination
Muhammad Asif 2, 65205 Wiesbaden, of IgG
Iqbal Germany i) ARCHITECT i Toxo antibodies to
IgG Reagent Kit (2x100 Toxoplasma
(FSC Germany Issuance Test) gondii in
Date 30-05-2017) Code: 07P4522 human serum
Shelf Life: 12 Months and plasma
Fee submitted: Rs.
50,000/- ii) ARCHITECT i Toxo
IgG Reagent Kit (2x500
Test)
Code: 07P4532
Shelf Life: 12 Months

iii) ARCHITECT i Toxo

IgG Calibrators
Code: 07P4501
Shelf Life: 12 Months

iv) ARCHITECT i Toxo

IgG Controls
Code: 07P4510
Shelf Life: 12 Months

392. -do- Legal Manufacturer/ ARCHITECT Toxo IgM IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C qualitative
Hafiz Co. KG Max-Planck-Ring detection of
Muhammad Asif 2, 65205 Wiesbaden, i) ARCHITECT Toxo IgM
Iqbal Germany IgM Reagent Kit (1x100 antibodies to
Tests) Toxoplasma
(FSC Germany Issuance Code: 6C20-25 gondii in
Date 19-07-2018) Shelf Life: 12 Months human serum
and plasma
Fee submitted: Rs. ii) ARCHITECT Toxo
244
 50,000/- IgM Reagent Kit (1x500
Tests)
Code: 6C20-35
Shelf Life: 12 Months

iii) ARCHITECT Toxo

IgM Calibrators
Code: 6C20-01
Shelf Life: 12 Months

iv) ARCHITECT Toxo

IgM Controls
Code: 6C20-10
Shelf Life: 12 Months

393. -do- Legal Manufacturer/ ARCHITECT i Toxo IVD Kit used Approved.
Manufacturing Site: IgM for the
Evaluator: M/s Abbott GmbH & qualitative
Hafiz Co. KG Max-Planck-Ring Class C detection of
Muhammad Asif 2, 65205 Wiesbaden, IgM
Iqbal Germany i) ARCHITECT i Toxo antibodies to
IgM Calibrator Toxoplasma
(FSC Germany Issuance Code: 07P4701 gondii in
Date 19-07-2018) Shelf Life: 09 Months human serum
and plasma
Fee submitted: Rs. ii) ARCHITECT i Toxo
50,000/- IgM Controls
Code: 07P4710
Shelf Life: 12 Months

iii) ARCHITECT i Toxo

IgM Reagent Kit (2x100
Tests)
Code: 07P4722
Shelf Life: 12 Months

iv) ARCHITECT i Toxo

IgM Reagent Kit (2x500
Tests)
Code: 07P4732
Shelf Life: 12 Months

394. -do- Legal Manufacturer/ ARCHITECT CA 19-9 IVD Kit used Approved.
Manufacturing Site: XR for the
Evaluator: M/s Abbott GmbH & quantitative
Hafiz Co. KG Max-Planck-Ring Class C determination
Muhammad Asif 2, 65205 Wiesbaden, of 1116-NS-19-
Iqbal Germany i) ARCHITECT CA 19-9 9 reactive
XR Reagent Kit determinants
(FSC Germany Issuance Code: 2K91-24 in human
Date 12-04-2017) Shelf Life: 12 Months serum or
plasma
245
 Fee submitted: Rs. ii) ARCHITECT CA 19-
50,000/- 9 XR Reagent Kit
Code: 2K91-32
Shelf Life: 12 Months
iii) ARCHITECT CA 19-
9 XR Reagent Kit
Code: 2K91-39
Shelf Life: 12 Months

iv) ARCHITECT CA 19-

9 XR Calibrators
Code: 2K91-03
Shelf Life: 12 Months

v) ARCHITECT CA 19-
9 XR Controls
Code: 2K91-12
Shelf Life: 12 Months

395. -do- Legal Manufacturer/ ARCHITECT i HAV IVD Kit used Approved.
Manufacturing Site: Ab-IgG for the
Evaluator: M/s Abbott GmbH & qualitative
Hafiz Co. KG Max-Planck-Ring Class C detection of
Muhammad Asif 2, 65205 Wiesbaden, IgG antibody
Iqbal Germany i) ARCHITECT i HAV to hepatitis A
Ab-IgG Calibrator virus (IgG
(FSC Germany Issuance Code: 08P2601 anti-HAV) in
Date 19-07-2017) Shelf Life: 12 Months human serum
and
Fee submitted: Rs. plasma
50,000/- ii) ARCHITECT i HAV
Ab-IgG Controls
Code: 08P2610
Shelf Life: 12 Months

iii) ARCHITECT i HAV

Ab-IgG Reagent Kit
(2x100 Tests)
Code: 08P2622
Shelf Life: 12 Months

iv) ARCHITECT i HAV

Ab-IgG Reagent Kit
(2x100 Tests)
Code: 08P2632
Shelf Life: 12 Months

396. -do- Legal Manufacturer/ Alinity i CA 15-3 IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) Alinity I CA 15-3 of DF3 defined
246
 Iqbal Germany Calibrators antigen in
Code: 08P5101 human serum
(FSC Germany Issuance Shelf Life: 12 Months and plasm
Date 12-04-2017)
ii) Alinity I CA 15-3
Fee submitted: Rs. Controls
50,000/- Code: 08P5110
Shelf Life: 12 Months

iii) Alinity I CA 15-3

Reagent Kit (2x100
Tests)
Code: 08P5120
Shelf Life: 12 Months

iv) Alinity I CA 15-3

Reagent Kit (2x500
Tests)
Code: 08P5130
Shelf Life: 12 Months

397. -do- Legal Manufacturer/ Alinity i CA 125 II IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) Alinity i CA 125 II of OC 125
Iqbal Germany Calibrators defined
Code: 08P4901 antigen in
(FSC Germany Issuance Shelf Life: 08 Months human serum
Date 19-07-2018) and Plasma
ii) Alinity i CA 125 II
Fee submitted: Rs. Controls
50,000/- Code: 08P4910
Shelf Life: 08 Months

iii) Alinity i CA 125 II

Reagent Kit (2x100
Tests)
Code: 08P4920
Shelf Life: 12 Months

iv) Alinity i CA 125 II

Reagent Kit (2x500
Tests)
Code: 08P4930
Shelf Life: 12 Months

398. -do- Legal Manufacturer/ Alinity i HAV Ab-IgM IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C qualitative
Hafiz Co. KG Max-Planck-Ring detection of
Muhammad Asif 2, 65205 Wiesbaden, i) Alinity i HAV Ab- IgG
247
 Iqbal Germany IgM Calibrators antibody to
Code: 02R2801 hepatitis A
(FSC Germany Issuance Shelf Life: 12 Months virus (IgG
Date 19-07-2018) anti-HAV) in
ii) Alinity i HAV Ab- human serum
Fee submitted: Rs. IgM Controls and plasma
50,000/- Code: 02R2810
Shelf Life: 12 Months

iii) Alinity i HAV Ab-

IgM Reagent Kit (2x100
Tests)
Code: 02R2822
Shelf Life: 12 Months

iv) Alinity i HAV Ab-

IgM Reagent Kit (2x500
Tests)
Code: 02R2832
Shelf Life: 12 Months

399. -do- Legal Manufacturer/ Alinity i Homocysteine IVD Kit used Approved.
Manufacturing Site: for the
Evaluator: M/s Abbott GmbH & Class C quantitative
Hafiz Co. KG Max-Planck-Ring determination
Muhammad Asif 2, 65205 Wiesbaden, i) Alinity i of total L-
Iqbal Germany Homocysteine homocysteine
Calibrators in human
(FSC Germany Issuance Code: 09P2801 serum or
Date 19-07-2018) Shelf Life: 15 Months plasma

Fee submitted: Rs. ii) Alinity i

50,000/- Homocysteine Controls
Code: 09P2810
Shelf Life: 80 Weeks

iii) Alinity i
Homocysteine Reagent
Kit (2x100 Tests)
Code: 09P2820
Shelf Life: 12 Months

===========

248