BEUDAMED
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    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

    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·

    Beijing HumaDX Tech Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Importer

    ZENA MAX EBV Epstein-Barr Real Time PCR Detection Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Advanced Molecular Diagnostics Ltd·1 device

    Winncare PAC Ltd

    Manufacturer
    1 Importer

    SpeeDx Pty. Ltd.

    Manufacturer
    🇦🇺 Australia·1 Basic UDI-DI·3 Devices·1 Importer

    Sino Medical Sciences Technology Inc.

    Manufacturer
    🇨🇳 China·42 Basic UDI-DIs·42 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    ACIST Medical Systems, Inc.

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·7 Devices·2 Importers

    DNA Genotek Inc.

    Manufacturer
    🇨🇦 Canada·10 Basic UDI-DIs·31 Devices·5 Importers

    NeoChord Inc.

    Manufacturer
    🇺🇸 United States