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  • Attachment CE-DOC-H073 Declaration of Conformity COVID-19

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    MusaMir
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    Healgen Scientific declares that their COVID-19 IgG/IgM Rapid Test Cassette conforms with the EU Directive 98/79/EC for in vitro diagnostic medical devices. The legal manufacturer is located in Houston, TX and their European authorized representative is Shanghai International Holding Corp. GmbH, located in Hamburg, Germany. Healgen declares the test cassette meets the provisions for in vitro diagnostic devices according to the directive.

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    Attachment Ⅰ CE-DOC-H073 Declaration of conformity COVID-19 - Copy - Copy - Copy

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    Healgen Scientific declares that their COVID-19 IgG/IgM Rapid Test Cassette conforms with the EU Directive 98/79/EC for in vitro diagnostic medical devices. The legal manufacturer is located in Houston, TX and their European authorized representative is Shanghai International Holding Corp. GmbH, located in Hamburg, Germany. Healgen declares the test cassette meets the provisions for in vitro diagnostic devices according to the directive.

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    504 views1 page

    Attachment CE-DOC-H073 Declaration of Conformity COVID-19

    Uploaded by

    MusaMir
    Healgen Scientific declares that their COVID-19 IgG/IgM Rapid Test Cassette conforms with the EU Directive 98/79/EC for in vitro diagnostic medical devices. The legal manufacturer is located in Houston, TX and their European authorized representative is Shanghai International Holding Corp. GmbH, located in Hamburg, Germany. Healgen declares the test cassette meets the provisions for in vitro diagnostic devices according to the directive.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    CE-DOC-H073

    version 1.0

    EC Declaration of Conformity
    In accordance with Directive 98/79/EC

    Legal Manufacturer: Healgen Scientific Limited Liability Company

    Legal Manufacturer Address: 3818 Fuqua Street, Houston, TX 77047, USA

    Declares, that the products


    Product Name and Model(s)

    COVID-19 IgG/IgM Rapid Test Cassette (Whole


    GCCOV-402a
    Blood/Serum/Plasma)

    Classification: Other
    Conformity assessment route: Annex III (EC DECLARATION OF CONFORMITY)

    We, the Manufacturer, herewith declare with sole responsibility that our product/s mentioned
    above meet/s the provisions of the Directive 98/79/EC of the European Parliament and of the
    Council on In-Vitro Diagnostic Medical Devices.

    We hereby explicitly appoint

    EC Representative’s Name: Shanghai International Holding Corp. GmbH (Europe)

    EC Representative’s Address: Eiffestrasse 80, 20537 Hamburg，Germany

    to act as our European Authorized Representative as defined in the aforementioned Directive.

    I, the undersigned,hereby declare that the medical devices specified above conform with the directive
    98/79/EC on in vitro diagnostic medical devices and pertinent essential requirements

    Date Signed: _February 19, 2020

    ____________________________________
    Name of authorized signatory: Joyce Pang
    Position held in the company: Vice-President

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