BEUDAMED
    16 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Certificate Type: Ivdd Annex Iii Section 6 ×

    VIROLOGY - RT & POC - OTHER

    Device
    EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries

    CLIN. CHEM. RT & POC - OTHER

    Device
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country

    SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·1 device

    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

    Vaginal pH Test Device

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

    2020-IVD/DE-006/A

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

    3EC International a.s.

    Notified body
    🇸🇰 Slovakia·97 Manufacturers·166 Basic UDI-DIs

    V9 042074 0032

    Certificate
    IVDD Annex III Section 6·Acon Biotech (Hangzhou) Co., Ltd.·TÜV SÜD Product Service GmbH·7 Basic UDI-DIs

    CeCert/091/W/E.1

    Certificate
    IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs

    CeCert/092/W/E.2

    Certificate
    IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs

    1434-IVDD-081/2022

    Certificate
    IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    1434-IVDD-217/2022

    Certificate
    IVDD Annex III Section 6·Hangzhou Alltest Biotech.Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-035/2022

    Certificate
    IVDD Annex III Section 6·Hangzhou Alltest Biotech.Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    1434-IVDD-079/2022

    Certificate
    IVDD Annex III Section 6·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·5 Basic UDI-DIs

    1431-IVDD-079/2022

    Certificate
    IVDD Annex III Section 6·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    CeCert/086/W/E.1

    Certificate
    IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs