BEUDAMED
    22 results · 9ms · 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 ×

    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.

    Sansure Biotech Inc.

    Manufacturer
    🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Beijing Strong Biotechnologies, Inc.

    Manufacturer
    🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH

    BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

    Manufacturer
    🇨🇳 China·43 Basic UDI-DIs·43 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·SG Medical Inc.·On the market

    AMMONIA

    Device
    EU IVDD · Eu Ivd General ·Beijing Strong Biotechnologies, Inc.·On the market

    VIROLOGY - RT & POC - OTHER

    Device
    EU IVDD · Eu Ivd Self Testing ·BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC·On the market

    SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·1 device

    SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·1 device

    SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·1 device

    SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·1 device

    InstaView COVID-19 Antigen Home Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·SG Medical Inc.·1 device

    1434-IVDD-197/2022

    Certificate
    IVDD Annex III Section 6·SG Medical Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-260/2022

    Certificate
    IVDD Annex III Section 6·Sansure Biotech Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs

    Ammonia Assay Kit (AMM)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beijing Strong Biotechnologies, Inc.·1 device

    CIBG-20222721

    Certificate
    IVDD Annex III Section 6·Beijing Strong Biotechnologies, Inc.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI