BEUDAMED
    3,242 results · 50ms · Sources: EU EUDAMED, US FDA

    DD 60135036

    Certificate
    MDD Annex V·GEM SRL·TUV Rheinland Italia SRL·11 Basic UDI-DIs

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENTRUST,SECURA,GEM II/III VR/DR,INTRINSIC/INTRINSIC 30,MAXIMO VR/DR,MAXIMO II,MARQUIS VR/DR,PROTECTA/PROTECTA XT

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720

    Voltage Gated Calcium Channel (Vgcc) Antibody Assay

    FDA classification
    FDA Class 2 ·Voltage Gated Calcium Channel (Vgcc) Antibody Assay

    α-Hydroxybutyrate Dehydrogenase Kit (DGKC Method)

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

    Chemistry Analyzer

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·11 devices

    Electrode, Ion Specific, Potassium

    FDA classification
    FDA Class 2 ·Electrode, Ion Specific, Potassium

    Alpha-1-Antitrypsin, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Alpha-1-Antitrypsin, Antigen, Antiserum, Control

    Carolina Liquid Chemistries Corp.

    FDA registration
    Carolina Liquid Chemistries Corp.·6 products·🇺🇸 United States

    Envoy 500+

    FDA registration
    BIOTECNICA INSTRUMENTS, Srl·6 products·🇮🇹 Italy

    NORMAL SALINE (NS)

    FDA registration
    Randox Teoranta·6 products·🇮🇪 Ireland

    SmartLyte Plus Electrolyte Analyzer

    FDA registration
    DIAMOND DIAGNOSTICS Inc·6 products·🇺🇸 United States

    Alinity c System

    FDA registration
    ABBOTT LABORATORIES·6 products·🇺🇸 United States

    GEM Premier 5000 (Instrument)

    FDA registration
    INSTRUMENTATION LABORATORY CO.·6 products·🇺🇸 United States

    JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM CGZ - ELECTRODE, ION-SPECIFIC, CHLORIDE

    FDA registration
    Siemens Healthcare Diagnostics Inc.·6 products·🇺🇸 United States

    Carolina Liquid Chemistries

    FDA registration
    Carolina Liquid Chemistries·6 products·🇺🇸 United States

    GEM Premier 5000 (Instrument)

    FDA registration
    INSTRUMENTATION LABORATORY CO. - Devens·6 products·🇺🇸 United States

    Rapidlab 348

    FDA registration
    Siemens Healthcare Diagnostics Inc.·6 products·🇺🇸 United States

    Analyzer

    FDA registration
    Diamond Diagnostics Inc.·6 products·🇭🇺 Hungary

    Alinity c System

    FDA registration
    ABBOTT LABORATORIES·6 products·🇺🇸 United States