BEUDAMED
    519 results · 8ms · 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 ×

    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（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

    SG Medical Inc.

    Manufacturer
    🇰🇷 South Korea·57 Basic UDI-DIs·57 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    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.

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

    Geratherm Medical GERMANY GmbH

    Manufacturer
    🇩🇪 Germany·20 Basic UDI-DIs·23 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    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

    Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

    Manufacturer
    🇨🇳 China·91 Basic UDI-DIs·115 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Hangzhou Realy Tech Co.,Ltd.

    Manufacturer
    🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

    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

    Pantest SA

    Manufacturer
    🇵🇹 Portugal·3 Basic UDI-DIs·3 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

    Manufacturer
    🇨🇳 China·6 Basic UDI-DIs·6 Devices·3 Importers·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Zhongshan Bio-Tech Co., Ltd.

    Manufacturer
    🇨🇳 China·24 Basic UDI-DIs·24 Devices·CeCert Sp. z o.o. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Atlas Medical GmbH

    Manufacturer
    🇩🇪 Germany·179 Basic UDI-DIs·179 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS

    Shenzhen Microprofit Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·13 Basic UDI-DIs·13 Devices·9 Importers·CeCert Sp. z o.o., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV SÜD Product Service GmbH

    CareforU.Co.Ltd

    Manufacturer
    🇰🇷 South Korea·6 Basic UDI-DIs·6 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    CIGA Healthcare Ltd

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

    OPTIX DOO BEOGRAD-ZEMUN

    Manufacturer
    🇷🇸 Serbia·1 Basic UDI-DI·1 Device·MDC MEDICAL DEVICE CERTIFICATION GMBH