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

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    3D-RA

    Device
    EU MDR · Eu Md Class 2b ·Philips Medical Systems Nederland B.V.·On the market·28 countries

    ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    3D-RA

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Philips Medical Systems Nederland B.V.·1 device

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    Heart Medical Europe B.V.

    Importer
    🇳🇱 Netherlands·10 Manufacturers

    Arseus Medical Group BV

    Importer
    🇳🇱 Netherlands·13 Manufacturers

    CEpartner4U

    Authorized representative
    🇳🇱 Netherlands·160 Manufacturers·5787 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    MedEnvoy Global BV

    Importer
    🇳🇱 Netherlands·234 Manufacturers