BEUDAMED
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    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT REALTIME HBV ASSAY/ CALIBRATOR KIT/CONTROL KIT & ABBOTT MSAMPLE PREPARATION SYSTEM DNA

    PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131

    FDA registration
    RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

    PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131

    FDA registration
    RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

    Medis Suite MRCT

    Device
    EU MDD · Eu Md Class 2a ·Medis Medical Imaging Systems bv·On the market·20 countries

    Medis Suite

    Device
    EU MDD · Eu Md Class 2a ·Medis Medical Imaging Systems bv·On the market·19 countries

    QFR

    Device
    EU MDR · Eu Md Class 2a ·Medis Medical Imaging Systems bv·On the market·18 countries

    Medis

    Device
    EU MDD · Eu Md Class 2a ·Medis Medical Imaging Systems bv·On the market·18 countries

    Hart Biologicals Ltd.

    Manufacturer
    2 Importers

    Boston Brace International, Inc.

    Manufacturer
    🇺🇸 United States

    OrthoPediatrics Canada ULC

    Manufacturer
    🇨🇦 Canada·143 Basic UDI-DIs·143 Devices·1 Importer

    Stealth Products, LLC.

    Manufacturer
    🇺🇸 United States·17 Basic UDI-DIs·17 Devices

    Chalice Medical Ltd

    Manufacturer
    30 Basic UDI-DIs·96 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

    JR Engineering & Medical Technologies (M) Sdn Bhd

    Manufacturer
    🇲🇾 Malaysia·3 Basic UDI-DIs·15 Devices·1 Importer

    Waters Corporation

    Manufacturer
    🇺🇸 United States·3 Basic UDI-DIs·30 Devices·1 Importer

    Confidence High Viscosity Spinal Cement

    FDA registration
    GMED Healthcare BV (a Johnson & Johnson Company)·1 product·🇬🇧 United Kingdom

    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 ·AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc

    cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System

    FDA UDI
    Roche Diagnostics GmbH·00875197004885·