BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Disposable electrodes for HST REM+

    Device
    EU MDR · Eu Md Class 1 ·CNSAC MedShop GmbH·On the market

    HomeSleepTest (HST, HST REM+)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Arzteingabe-Modul (AEM)

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Mesalvo Freiburg GmbH·1 device

    Sunrise Medical GmbH

    Importer
    🇩🇪 Germany·2 Manufacturers

    REP Europe GmbH

    Authorized representative
    🇩🇪 Germany·52 Manufacturers·263 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices

    MedNet EC-REP IIb GmbH

    Authorized representative
    🇩🇪 Germany·32 Manufacturers·165 Devices

    MedNet EC-REP III GmbH

    Authorized representative
    🇩🇪 Germany·14 Manufacturers·45 Devices

    MedNet EC-REP C IIb GmbH

    Authorized representative
    🇩🇪 Germany·36 Manufacturers·989 Devices

    MedNet EC-REP C III GmbH

    Authorized representative
    🇩🇪 Germany·12 Manufacturers·77 Devices

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices