BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    AIDS, FURNITURE AND HOME AIDS FOR PERSONS WITH DISABILITIES - OTHER

    Device
    EU MDR · Eu Md Class 1 ·CloudCuddle·On the market·6 countries

    3mensio Workstation (Vascular Fenestrated) software

    FDA Enforcement
    Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

    G1 098021 0005

    Certificate
    MDD Annex II (excluding section 4)·Pie Medical Imaging B.V.·TÜV SÜD Product Service GmbH·23 Basic UDI-DIs

    StartDock Rotterdam B.V.

    Authorized representative
    🇳🇱 Netherlands·1 Manufacturer

    Koopman International

    Importer
    🇳🇱 Netherlands·5 Manufacturers

    Dayes Europe B.V.

    Importer
    🇳🇱 Netherlands·8 Manufacturers

    Lotus NL B.V.

    Authorized representative
    🇳🇱 Netherlands·584 Manufacturers·21427 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices