BEUDAMED
    6,219 results · 41ms · Sources: EU EUDAMED, US FDA

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

    MatrixPRO II Single Use Battery

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Pro-Dex, Inc.·1 device

    Hemoglobin electrophoresis kit 200 tests

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Seleo S.r.l.·1 device

    170774418

    Certificate
    MDD Annex II Section 4·BHM-Tech Produktionsgesellschaft m.b.H.·DQS Medizinprodukte GmbH·55 Basic UDI-DIs

    Abmed Medical Technology Limited

    Importer
    🇮🇪 Ireland

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)

    Trinity Biotech

    FDA UDI
    MARDX DIAGNOSTICS, INC.·05391516747585·Phosphate Buffered Saline, 10g

    UpDental OÜ

    Importer
    🇪🇪 Estonia·2 Manufacturers

    EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

    FDA UDI
    EUROIMMUN Medizinische Labordiagnostika AG·04049016124887·

    EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

    FDA UDI
    EUROIMMUN Medizinische Labordiagnostika AG·04049016124894·

    Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)

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

    CBM LIFEMOTION S.R.L.

    Authorized representative
    🇮🇹 Italy·1 Manufacturer·19 Devices

    AIM-Medical Kft.

    Importer
    🇭🇺 Hungary·3 Manufacturers

    Disposable vinyl gloves

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Tangshan Hongyun Healthcare Products Co.,Ltd.·4 devices

    HBI Health & Beauty International GmbH

    Importer
    🇩🇪 Germany

    Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

    FDA classification
    FDA Class 2 ·Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

    FDA classification
    FDA Class 2 ·Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control