BEUDAMED
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    OnSite HIV 1/2 Ab Plus Combo Rapid Test

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·CTK Biotech Inc.·On the market·1 country

    Assure Tech. (Hangzhou) Co., Ltd.

    Manufacturer
    🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

    CTK Biotech Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·3EC International a.s.

    OnSite HIV 1/2 Ab Plus Combo Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·CTK Biotech Inc.·1 device

    No.2020-IVD/QS-008

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·CTK Biotech Inc.·3EC International a.s.·1 Basic UDI-DI