Scribd Logo
Upload

Welcome to Scribd!

  • 80 views

    Covid-19 One-Step RT-PCR Kit - CE - EAR Certificate

    Uploaded by

    Harun Ganić
    The document is a certificate from Obelis s.a. declaring that Meril Diagnostics Pvt Ltd. has appointed Obelis s.a. as its authorized European representative, as required by the EU Directive 98/79/EC for in vitro diagnostic medical devices. The certificate lists 9 medical devices produced by Meril Diagnostics along with their intended use and risk classification. Obelis s.a. confirms it is fulfilling its role as the European authorized representative for Meril Diagnostics in accordance with EU regulations.

    Copyright:

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

    Covid-19 One-Step RT-PCR Kit - CE - EAR Certificate

    Uploaded by

    Harun Ganić
    80 views3 pages
    The document is a certificate from Obelis s.a. declaring that Meril Diagnostics Pvt Ltd. has appointed Obelis s.a. as its authorized European representative, as required by the EU Directive 98/79/EC for in vitro diagnostic medical devices. The certificate lists 9 medical devices produced by Meril Diagnostics along with their intended use and risk classification. Obelis s.a. confirms it is fulfilling its role as the European authorized representative for Meril Diagnostics in accordance with EU regulations.

    Original Description:

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document is a certificate from Obelis s.a. declaring that Meril Diagnostics Pvt Ltd. has appointed Obelis s.a. as its authorized European representative, as required by the EU Directive 98/79/EC for in vitro diagnostic medical devices. The certificate lists 9 medical devices produced by Meril Diagnostics along with their intended use and risk classification. Obelis s.a. confirms it is fulfilling its role as the European authorized representative for Meril Diagnostics in accordance with EU regulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    80 views3 pages

    Covid-19 One-Step RT-PCR Kit - CE - EAR Certificate

    Uploaded by

    Harun Ganić
    The document is a certificate from Obelis s.a. declaring that Meril Diagnostics Pvt Ltd. has appointed Obelis s.a. as its authorized European representative, as required by the EU Directive 98/79/EC for in vitro diagnostic medical devices. The certificate lists 9 medical devices produced by Meril Diagnostics along with their intended use and risk classification. Obelis s.a. confirms it is fulfilling its role as the European authorized representative for Meril Diagnostics in accordance with EU regulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    ONSIBLE

    SP P
    RE

    ER
    EUROPEAN

    SO
    N CENTER
    E.A.R.-CERTIFICATE
    (ART 10.3 of the Directive 98/79/EC on In Vitro Diagnostic)

    ref. no. : GZ 9191-2020

    order no. : GZ 9069-2020 date: 14/05/2020

    Manufacturer: Meril Diagnostics Pvt Ltd., Facilities: Meril Diagnostics Pvt Ltd.,
    Second floor, D1-D3, Meril Second floor, D1-D3, Meril
    Park, Survey No 135/2/B, Park, Survey No 135/2/B,
    174/2, Muktanand Marg, Chala, 174/2, Muktanand Marg, Chala,
    Vapi 396191, Gujarat, India Vapi 396191, Gujarat, India

    Product Please See Annex A - List of Devices (9 Devices, 2 Pages )


    Categories:

    Models: Please See Annex A - List of Devices (9 Devices, 2 Pages )

    The European Authorized Representative Center Obelis s.a. declares that the aforementioned manufacturer
    has fulfilled the essential requirement of appointing a European Authorized Representative in accordance
    with article 10.3 of the Directive 98/79/EC and to the terms and conditions set out in the agreement entered into force
    on May 1st 2015.*

    Mr. G. Elkayam CEO


    Obelis sa
    Obelis European Authorized Representative Center is a member of the European Association of
    Authorized Representatives (E.A.A.R.), ISO 9001 : 2015 and ISO 13485 : 2016 certified in accordance
    to the profession of a European Authorized Representative.
    * This is not a CE mark and is only provided
    as a template for informational purposes.
    *This certificate is not a confirmation of product notification nor an approval to place products on the market.
    **This certificate will become void automatically upon termination of the EAR agreement.

    Registered Address : Bd. Général Wahis 53 - 1030 Brussels I Registered Office Address : Bd Brand Whitlock 30, B-1200 Brussels - Belgium
    T: + 32 (0) 2 732 5954 I F: + 32 (0) 2 732 6003 I Email: [email protected] I Website: www.obelis.net
    V3 - ID: 00453116 - 22/02/2019
    Order No.: GZ 9069-2020
    Ref No.: GZ 9191-2020

    Annex A - List of Devices


    (Recital 29 of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices)
    Catalogue Short description and GMDN/
    # Commercial Name Generic Device Term Class
    reference number intended use EDMS Code
    NCVPCR-01
    1. MERIL COVID-19 One-Step RT-PCR Kit As per pack insert 64747 Non-Listed
    NCVPCR-02
    NCVRPD-01
    2. NCVRPD-02 MERIL COVID-19 IgG/IgM Rapid Test As per pack insert 64756 Non-Listed
    NCVRPD-03
    MHLRPD-02
    MHLRPD-03 MERISCREEN Malaria
    3. One Step Test for Malaria Pf/Pan Ag As per pack insert 52311 Non-Listed
    MHLRPD-04 Pf/Pan Ag
    MHLRPD-05
    MFLRPD-03 MERISCREEN Malaria Pf/Pv
    4. One Step Test for Malaria Pf/Pv Ag As per pack insert 52311 Non-Listed
    MFLRPD-04 Ag
    RPWMPH-02
    MERISCREEN Malaria Pf
    5. RPWMPH-03 One Step Test for Malaria Pf HRP ll Ag As per pack insert 52336 Non-Listed
    HRP ll Ag
    RPWMPH-04
    One Step test Rapid Test for detection of
    HVWRPD-01
    6 MERISCREEN HIV 1-2 WB anti-HIV in Human Serun/Plasma/Whole As per pack insert 48447 List A
    HVWRPD-02
    blood
    7 RPDHBV-01 MERISCREEN HBsAg One Step Rapid Test for HBsAg As per pack insert 48322 List A
    8 RPDHCV-01 MERISCREEN HCV One Step Rapid Test for HCV As per pack insert 30829 List A
    Enzyme immunoassay for the detection
    9 HPCELI-01 Merilisa HCV of antibodies to Hepatitis C Virus in As per pack insert 48365 List A
    human serum or plasma

    Attachments – Annex to DoC IVD – ID # 00207717 – V1 – 08/11/2017


    Page 1 of 2
    Obelis s.a.

    Signature:
    __________

    Date:
    14/05/2020
    ______________

    Stamp:

    Attachments – Annex to DoC IVD – ID # 00207717 – V1 – 08/11/2017


    Page 2 of 2

    You might also like