BEUDAMED
    46 results · 8ms · Sources: EU EUDAMED, US FDA

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    Immunoglobulin (IgA/IgG/IgM) Reagent Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·1 device

    SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

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

    SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

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

    SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

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

    SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

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

    Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

    HZ 2100551-1

    Certificate
    MDR QMS·MANI, INC.·TÜV Rheinland LGA Products GmbH

    9777

    Certificate
    MDD Annex II (excluding section 4)·Coroneo Inc.·GMED SAS·48 Basic UDI-DIs

    0068/QCO-DM/074-2017

    Certificate
    MDD Annex II (excluding section 4)·AMI INC.·MTIC InterCert S.r.l.·5 Basic UDI-DIs

    0068/QCO-DM/074-2017

    Certificate
    MDD Annex II (excluding section 4)·AMI INC.·MTIC InterCert S.r.l.·23 Basic UDI-DIs

    10397

    Certificate
    MDD Annex II Section 4·Coroneo Inc.·GMED SAS·5 Basic UDI-DIs

    KR19/81826295

    Certificate
    MDD Annex II (excluding section 4)·MF / SEWONMEDIX Inc.·SGS Belgium NV·26 Basic UDI-DIs

    KR19/81826295

    Certificate
    MDD Annex II (excluding section 4)·MF / SEWONMEDIX Inc.·SGS Belgium NV·1193 Basic UDI-DIs

    No. V1 074552 0011 Rev. 02

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

    CeCert/115/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/116/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/117/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/118/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/119/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/120/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI