BEUDAMED
    61 results · 7ms · 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 ×

    BGI EUROPE A/S

    Manufacturer
    🇩🇰 Denmark·103 Basic UDI-DIs·116 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    BGI

    Device
    EU IVDD · Eu Ivd Self Testing ·BGI EUROPE A/S·On the market

    D-tek s.a.

    Manufacturer
    🇧🇪 Belgium·77 Basic UDI-DIs·77 Devices·SGS United Kingdom Limited, SGS United Kingdom Limited, and SGS United Kingdom Limited

    Shenzhen Zijian Biotechnology Co., Ltd

    Manufacturer
    🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

    SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·BGI EUROPE A/S·1 device

    Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.

    Manufacturer
    🇨🇳 China·86 Basic UDI-DIs·107 Devices·5 Importers·TÜV Rheinland LGA Products GmbH, SGS Belgium NV, and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    1434-IVDD-011/2022

    Certificate
    IVDD Annex III Section 6·BGI EUROPE A/S·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    BlueDot Myositis12 SAE IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot Cytoplasm6 IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot ENA6 IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot ANA12 Screen IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot ANA12 IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot ANA8 IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot ANCA+GBM IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot GAD IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot Gastritis IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot Milk Intolerance IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot ASCA IgG + IgA

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot Celiac IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot Celiac IgA

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries