Scribd Logo
Upload

Welcome to Scribd!

  • 16 views

    TD - Ecd.01 EC Declaration Detrowash MDR

    Uploaded by

    murgucatalina77

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    TD - Ecd.01 EC Declaration Detrowash MDR

    Uploaded by

    murgucatalina77
    16 views12 pages

    Original Title

    TD.ecd.01 EC Declaration Detrowash MDR

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    16 views12 pages

    TD - Ecd.01 EC Declaration Detrowash MDR

    Uploaded by

    murgucatalina77

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 12

    “Pursuant to the provisions of Regulation (EU) No.

    2023/607 issued by the European Commission,


    devices regulated in accordance with Directive 93/42/EEC, provided that they fulfill the conditions
    specified in this Regulation:

     December 31, 2027 for class III devices and class IIb implantable devices excluding sutures,
    staples, dental fillings, dental brackets, dental crowns, screws, wedges, plates, wires, pins,
    clips and connectors;

     December 31, 2028 for class IIb devices other than those covered above, class IIa devices and
    class I devices placed on the market in sterile condition or with a measuring function

     Devices for which the conformity assessment procedure under Directive 93/42/EEC does not
    require the involvement of a notified body, for which a declaration of conformity was issued
    before 26 May 2021 and for which the conformity assessment procedure under the MDR
    requires the involvement of a notified body 31 December 2028

    until the dates of 2017/745 EU Medical Device Regulation.

    Within the scope of Announcement No. 2023/KK-5 on the Implementation of the Provisions of
    Regulation (EU) No. 2023/607, our company has signed the official contract with SZUTEST GMBH
    Notified Body in order to carry out the certification process in accordance with the 2017/745 EU
    Medical Device Regulation in force and our review processes have been initiated. At the same time,
    an MDD Surveillance Audit contract was signed with SZUTEST Conformity Assessment Inc. Notified
    Body in order to extend our MDD Certificate, which will expire on 26.05.2024, until 26.09.2024 in
    accordance with the 93/42/AT Medical Device Directive.

    After the application made to the Competent Authority within the scope of Announcement No.
    2023/KK-5, our MDR Transition Period Extension process has been approved and the attached cover
    letter has been received.”
    Doküman No TD.ECD.01
    EC DEKLARASYON / Yayın Tarihi 15.05.2013
    EC DECLARATION Revizyon No 9
    Revizyon Tarihi 24.08.2022

    AT UYGUNLUK BEYANI

    EC DECLARATION OF CONFORMITY

    Tıbbi Cihaz Yönetmeliği (93/42/AT)- Medical Devices Directive 93/42/EEC

    Medical Device Directive (93/42/EEC)


    Firma Adı
    : Detro Healthcare Kimya Sanayi A.Ş.1
    Company Name
    Adres
    : Atatürk Mah. Cemal Gürsel cd. No:8/3 Esenyurt / İSTANBUL2
    Address

    Detro Healthcare, yetkili otorite SZUTEST Uygunluk Değerlendirme A.Ş. Onaylanmış Kuruluş No.2195
    tarafından değerlendirilmiştir. Bu deklerasyon Tıbbi Cihaz Direktifi 93/42/AT ‘ye uyumlu olarak
    hazırlanmıştır.
    Detro Healthcare having been assesed by SZUTEST Uygunluk Değerlendirme A.Ş. Notified Body
    No.2195. This declaration is made in accordance 93/42/EEC.

    EK-1 Tablo’sunda listelenen Endoskop Yıkama ve Dezenfeksiyon Cihazı ürünleri aşağıdaki tabloda yer
    alan standartlara göre üretilmiştir.
    Endoskop Yıkayıcı ve Dezenfektör Cihazı ürünlerimizin
    Tıbbi Cihaz Yönetmeliği 93/42/AT Ek II (Madde 4 Hariç)
    Tam Kalite Güvence Sistemi
    Tıbbi Cihaz Dezenfektanı - Sınıf IIb
    (93/42/AT Ek IX, Kural15)
    Detrowash cihazlarımızın (Ek1’e bakınız.) bu hükümlere uygun olduğunu beyan ederiz.

    Our Endoscope cleaner and Disinfector Device products that listed EK-1 Table produced according to
    standards below.
    Full Quality Assurance System
    Medical Device Dissenfection - Class IIb
    (93/42/EEC Annex IX, Rule 15)
    We declare that our Detrowash Devices (See Annex1. ) complies with its terms.

    EN ISO 13485:2016 EN 14155: 2011 EN 62366: 2008 EN 20417:2021

    EN ISO 14971:2019 EN 61010-1: 2010 EN 60601-1-6: 2010 EN ISO 15883-4:2019

    EN 15223-1:2021 EN 61326-1: 2013 EN ISO 15883-1: 2009

    EN 62304: 2006

    1
    05.06.2017 Tarihinde Yapılan 3. Revizyon
    2 19.02.2021 Tarihinde yapılan 8. revizyon
    1/3
    Doküman No TD.ECD.01
    EC DEKLARASYON / Yayın Tarihi 15.05.2013
    EC DECLARATION Revizyon No 9
    Revizyon Tarihi 24.08.2022

    Onaylanmış Kuruluş
    : Szutest Uygunluk Değerlendirme A.Ş.
    Notified Body
    Onaylanmış Kuruluş Kimlik
    Numarası : 2195
    Notified Body Identify Number
    Sertifika No
    : 2195-MED-1118102
    Certificate No
    Sertifika Yayın Tarihi
    : 30.06.2011
    Certificate Publication Date
    Sertifika Geçerlilik Tarihi
    : 28.04.20243
    Sertifika Validity Date
    Beyan Tarihi
    : 05.06.20174
    Declaration Date
    Beyan Yeri
    : İstanbul
    Declaration Location
    Beyanda Bulunan / Unvan
    : Şevket Kılıç/Genel Müdür/ General Manager
    Authorized in Declaration/ Title

    Onay
    :
    Approve

    4
    05.06.2017 Tarihinde Yapılan 3. Revizyon
    2/3
    Doküman No TD.ECD.01
    EC DEKLARASYON / Yayın Tarihi 15.05.2013
    EC DECLARATION Revizyon No 9
    Revizyon Tarihi 24.08.2022

    EK-1 Ürün Model ve GMDN Kodu Tablosu


    EK-1 Product Model and GMDN Code Table
    Ürün Ürün
    Ürün İsmi Marka Modelleri Marka Modelleri
    GMDN
    Product Name Brand Product Brand Product
    Models Models
    DW 5001
    DW 5002
    DW 5003
    DW 5004 STR 5004
    DW 5005
    DW 6001
    DW 6002 35012
    DW 6003 STR 6003
    Endoskop Yıkayıcı DW 6004 Endoskop yıkayıcı /
    Dezenfektör Cihazı / DW 6005 dezenfektör
    DETROWASH STERIWASH
    Endoscope Cleaner DW 7001 / Endoscope cleaner
    Disenfector Device DW 7002 disenfector
    DW 7003
    DW 7004 STR 7004
    DW 7005
    DW 8001
    DW 8002
    DW 8003 STR 8003
    DW 8004
    DW 8005

    HAZIRLAYAN ONAYLAYAN
    YÖNETİM TEMSİLCİSİ GENEL MÜDÜR

    3/3

    You might also like