BEUDAMED
    10 results · 8ms · Sources: EU EUDAMED, US FDA

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    Merlin Biomedical (Xiamen) Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.

    Nucleix

    Manufacturer
    🇮🇱 Israel

    Sanway Gene Tech. Inc.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    SARS-CoV-2 Antigen Rapid Test Cassette

    Device
    EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

    HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·On the market·3 countries

    SARS-CoV-2 Antigen Rapid Test Cassette

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·1 device

    CeCert/037/W/E.1

    Certificate
    IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

    1434-IVDD-198/2022

    Certificate
    IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-199/2022

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI