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    Sertifikat CPAKB

    Uploaded by

    Azka Rahman
    This certificate is issued to PT. Sinko Prima Alloy located in Surabaya, Indonesia, certifying that the company has met the requirements for a Certificate of Good Manufacturing Practice for Medical Devices. The certificate is valid until October 11, 2021 and covers the production of ear, nose, and throat equipment; obstetrics and gynecology equipment; physical health equipment; and radiology equipment. These include items like sinus irrigators, hearing aids, ultrasound gel, fetal monitors, obstetric chairs, ultrasound monitors, and more.

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    © All Rights Reserved
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    Sertifikat CPAKB

    Uploaded by

    Azka Rahman
    41 views1 page
    This certificate is issued to PT. Sinko Prima Alloy located in Surabaya, Indonesia, certifying that the company has met the requirements for a Certificate of Good Manufacturing Practice for Medical Devices. The certificate is valid until October 11, 2021 and covers the production of ear, nose, and throat equipment; obstetrics and gynecology equipment; physical health equipment; and radiology equipment. These include items like sinus irrigators, hearing aids, ultrasound gel, fetal monitors, obstetric chairs, ultrasound monitors, and more.

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    4. Sertifikat CPAKB

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    This certificate is issued to PT. Sinko Prima Alloy located in Surabaya, Indonesia, certifying that the company has met the requirements for a Certificate of Good Manufacturing Practice for Medical Devices. The certificate is valid until October 11, 2021 and covers the production of ear, nose, and throat equipment; obstetrics and gynecology equipment; physical health equipment; and radiology equipment. These include items like sinus irrigators, hearing aids, ultrasound gel, fetal monitors, obstetric chairs, ultrasound monitors, and more.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    41 views1 page

    Sertifikat CPAKB

    Uploaded by

    Azka Rahman
    This certificate is issued to PT. Sinko Prima Alloy located in Surabaya, Indonesia, certifying that the company has met the requirements for a Certificate of Good Manufacturing Practice for Medical Devices. The certificate is valid until October 11, 2021 and covers the production of ear, nose, and throat equipment; obstetrics and gynecology equipment; physical health equipment; and radiology equipment. These include items like sinus irrigators, hearing aids, ultrasound gel, fetal monitors, obstetric chairs, ultrasound monitors, and more.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    I(EMENTERIAN I(ESEIIATAN .

    REPUBLII( INDONESIA
    DIREKTORAT JENDERAL I(EFARN4ASIAN DAN ALAT I(ESEHATAN
    DIREKTORAT PENGAWASAN ALAT KESEI{ATAN DAN PKRT
    !\{tr{ISTR7'OF I'IE;1LTI{ - fuEPLIBLIC Of INDONESIA
    D I R E T' 7-O k47'E G E N t: lLl t- O F P H :1 1l MA(' E{ ! 7" 1 (- A L AN D M E D I (' A L D r: t/ I ( E S
    DIRE(T)V4I'E OF P).STYLARKET'|'ON7'ROL OF MEDIC.LLDEII('ES.|ND M\|SEIIOLD PROD{iCT

    SERTHP'IKAT
    A CERTfT{CATE
    CARA PEMBUATAN ALAT KESEHATAN YANG BAIK
    GOOD 144NL.(;A{'T{/PJI,{C PLAL-TICE FOR MEDICAI. DETICES

    NoMoR frfff3l#;l;;|l;;if
    N{/MBER

    Diberikan kepada
    Prcsenled ta
    PT. SINKO PRIMA ALLOY
    Tambak Osowilangon Permai E7 - 8, Surabaya

    Telah memeaehi sy&rat untuk merdapatkan


    Sertifikat Cara Pembuatan Alat Kesehatan yang Baik
    Has bee* approved to get Cert'trtcatu af Good Manufacturing Practice for Medical Deviees

    Ruang lingkup
    Scope

    Produksi Peralatan Telinga, Hidung dan Tenggorokan : Sinus


    lrrigator/Powered Nasal Irrigator, Hearing Aid ; Peralatan Obstetrik dan
    Ginekologi : USG Gel, Fetal Monitor, Fetal Stethoscope, Fetal Cardiac
    Monitor, Maternal Fetal Monitor, Obstetric Chair, USG Monitor, Fetal
    Doppler, USG, Breast Pump ; Peralatan Kesehatan Fisik : Flotation
    Cushion, Bathroom Aid & Safety, Daily Activity Asist Device,
    WalkeriWalking Aid, Crutch, Cane, Rollator, Commode Chair, Wheel
    Chair, Exercise Equipment, Cold or Hot Pack, Traction Equipment,
    Powered Heating Unit, Infrared Lamp, Powered Heating Pad ; Peralatan
    Radiologi : Ultrasonic Medical Image Workstation, Tele radiologi, USG
    Monitor

    A.n Direktur Jenderal


    Direktur PengawasanAlat Kesehatan dan PKRT
    Thnggal Persetujuan
    On Behalf of Director General
    Apprct,al Dale
    Director of Post Market Control of Medical Devices
    I I oCT 20t6 and Household Product

    Berlaku hingga
    l/alicl thru

    II oCT 2021
    lll"Kes.
    t".+,$W 3 1986031004

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