BEUDAMED
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    Haier Haematologi Chongqing Co., Ltd.

    Manufacturer
    🇨🇳 China·TÜV Rheinland LGA Products GmbH

    Qingdao Haier Biomedical Co.,Ltd.

    Manufacturer
    🇨🇳 China·2 Importers

    CenterPoint Systems LLC

    Manufacturer
    🇺🇸 United States·4 Basic UDI-DIs·4 Devices·GMED SAS

    BIOSTI (Swiss technology of implantology and biomaterials) GmbH

    Manufacturer
    🇨🇭 Switzerland

    HEALQU LLC.

    Manufacturer
    🇺🇸 United States·5 Basic UDI-DIs·5 Devices

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM

    Calcium Kit (Arsenazo Ⅲ Method)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS

    Epstein-Barr Virus(EBV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

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

    FDA Pre-Market Approval
    FDA Class 3 ·ANTI-HBS

    Guangzhou Decheng Biotechnology Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·2 Importers

    Shenzhen Superbio Technology Co.,Ltd.

    Manufacturer
    🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Guangzhou Wondfo Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·10 Importers

    Shenzhen Tisenc Medical Devices Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Importer

    Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit

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

    Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit

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

    Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR