BEUDAMED
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    Filters Certificate Type: Ivdd Annex Iii Section 6 ×

    Nanjing Synthgene Medical Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·83 Basic UDI-DIs·83 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Nanjing Genscript Diagnostics Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·2 Basic UDI-DIs·2 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method)

    Device
    EU IVDD · Eu Ivd Self Testing ·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market·3 countries

    CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Nanjing Genscript Diagnostics Technology Co., Ltd.·On the market

    SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nanjing Synthgene Medical Technology Co., Ltd. ·1 device

    SARS-CoV-2 Neutralizing Antibody Detection Kit (Latex immunochromatography-blocking sandwich method)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nanjing Genscript Diagnostics Technology Co., Ltd.·1 device

    1434-IVDD-110/2022

    Certificate
    IVDD Annex III Section 6·Nanjing Genscript Diagnostics Technology Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-173/2022

    Certificate
    IVDD Annex III Section 6·Nanjing Synthgene Medical Technology Co., Ltd. ·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI