BEUDAMED
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    3mensio Workstation (Vascular Fenestrated) software

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

    db-die Beraterapotheke B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    G1 098021 0005

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

    Amstermed B.V.

    Authorized representative
    🇳🇱 Netherlands·50 Manufacturers·272 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices