BEUDAMED
    16 results · 19ms · 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

    CeliacDetect (EN/ES/IT/POL)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    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

    Screen Test Candida (IT/EN/ES/PL/FR/HU/PT/RO)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    Screen Test Celiachia (IT/EN/ES/PL/FR/HU/PT/RO)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    HCV ANTIBODY -RT & POC

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

    HBSAG - RT & POC

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

    HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

    HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device