BEUDAMED
    78 results · 26ms · 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 Regulation: Eu Ivdd ×

    Diagnostic Kit for TES (Testosterone) (Time-resolved Fluorescence Immunochromatographic Assay)

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

    BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)

    Device
    EU IVDD · Eu Ivd General ·Hunan Kangxin Biotechnology Co., Ltd.·On the market·32 countries

    CORONAVIRUS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·On the market·32 countries

    D-DIMER

    Device
    EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·On the market·32 countries

    BioCLIA Autoimmune Control Set, LKM-1

    Device
    EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

    geneMAP

    Device
    EU IVDD · Eu Ivd General ·GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ·On the market

    Diagnostic Kit for TES (Testosterone) (Time-resolved Fluorescence Immunochromatographic Assay)

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

    SARS-CoV-2 IgM (CLIA)

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

    N-terminal proBNP Kit (Microfluidic Fluorescent Immunoassay)

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

    NF-light ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·UmanDiagnostics 5566982418·1 device

    Omixon HLA TWIN

    Device
    EU IVDD · Eu Ivd General ·Omixon Biocomputing Ltd.·On the market·11 countries

    Holotype HLA 24/7 - Configuration A1 & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·9 countries

    Holotype HLA 96/7 - Configuration C & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·7 countries

    Holotype HLA 96/7 - Configuration B & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·7 countries

    Holotype HLA 96/5 - Configuration C & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·5 countries

    Holotype HLA 96/5 - Configuration A & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·4 countries

    Holotype HLA 96/5 - Configuration B & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·4 countries

    Holotype HLA 96/11 - Configuration C & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·6 countries

    Holotype HLA 96/11 - Configuration B & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·6 countries

    Holotype HLA 96/11 - Configuration A & CE v2

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Omixon Biocomputing Ltd.·On the market·6 countries