BEUDAMED
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    SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）

    Device
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·On the market

    Sansure Biotech Inc.

    Manufacturer
    🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    CeCert/115/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/117/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/119/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    1434-IVDD-260/2022

    Certificate
    IVDD Annex III Section 6·Sansure Biotech Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs

    No. V1 074552 0011 Rev. 02

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

    CeCert/116/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/118/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/120/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

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

    Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market·3 countries

    Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

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

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Sansure Biotech Inc.·On the market·5 countries

    Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing)

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Sansure Biotech Inc.·On the market·9 countries

    Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Sansure Biotech Inc.·On the market·6 countries