BEUDAMED
    6,704 results · 40ms · Sources: EU EUDAMED, US FDA

    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

    Advocate Blood Pressure Monitor, Wrist, Model SPBP-02, Bilingual

    FDA UDI
    DIABETIC SUPPLY OF SUNCOAST, INC.·00894046001516·Advocate Blood Pressure Monitor, Wrist, Model S...

    Total β Human Chorionic Gonadotrophin（CLIA）、Total β HCG Calibrators

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

    Normalizing Quantitative Electroencephalograph Software

    FDA classification
    FDA Class 2 ·Normalizing Quantitative Electroencephalograph Software

    Nettle

    Device
    EU MDR · Eu Md Class 2a ·Samphire Neuroscience Ltd·On the market·15 countries

    Oxygen Therapy Chamber Lower Extremity Boot

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GHC Co., Ltd.·1 device

    Oxygen Therapy Torso Unit With Adhesive

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GHC Co., Ltd.·1 device

    OPL2 RegularSize

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GHC Co., Ltd.·1 device

    OPL1 Large size

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GHC Co., Ltd.·1 device

    FMAbsorb fluid absorption pads

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GHC Co., Ltd.·1 device

    Contained Wound Irrigation Bag

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GHC Co., Ltd.·1 device

    Contained Wound Irrigation Bag

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GHC Co., Ltd.·1 device

    Test, Immunoassay, Biosensor, Hcg

    FDA classification
    FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C

    GHC German Health Care GmbH

    Importer
    🇩🇪 Germany·7 Manufacturers

    Visual, Pregnancy Hcg, Prescription Use

    FDA classification
    FDA Class 2 ·Visual, Pregnancy Hcg, Prescription Use

    Nitrile Examination Gloves

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Hartalega NGC Sdn. Bhd.·29 devices

    Natural Rubber Latex Surgical Gloves

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Hartalega NGC Sdn. Bhd.·6 devices

    Antimicrobial Nitrile Examination Gloves (AMG)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Hartalega NGC Sdn. Bhd.·37 devices

    Sterile Nitrile Examination Gloves

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Hartalega NGC Sdn. Bhd.·4 devices