BEUDAMED
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    Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    Suction Tube Ch 27, 300 cm

    Device
    EU MDR · Eu Md Class 1 ·Dispo Medical B.V.·On the market

    DR,SHEET,SPUN,195X145

    Device
    EU MDR · Eu Md Class 1 ·Medica Europe B.V.·On the market·2 countries

    HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Duo-Med BV

    Importer
    🇳🇱 Netherlands

    Humeca B.V.

    Manufacturer
    🇳🇱 Netherlands·78 Basic UDI-DIs·78 Devices·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    OrbusNeich Medical, B.V.

    Manufacturer
    🇳🇱 Netherlands·508 Basic UDI-DIs·508 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

    LifeTech Scientific (Europe) B.V.

    Manufacturer
    🇳🇱 Netherlands·792 Basic UDI-DIs·792 Devices·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    Royal Utermöhlen

    Manufacturer
    🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.

    Aqtis Medical B.V.

    Manufacturer
    🇳🇱 Netherlands·8 Basic UDI-DIs·8 Devices·DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    Technomed Europe

    Manufacturer
    🇳🇱 Netherlands·457 Basic UDI-DIs·695 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.

    Nutricia Medical Devices BV

    Manufacturer
    🇳🇱 Netherlands·26 Basic UDI-DIs·73 Devices·DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    Philips Medical Systems Nederland B.V.

    Manufacturer
    🇳🇱 Netherlands·68 Basic UDI-DIs·355 Devices·DEKRA Certification B.V., BSI Group The Netherlands B.V., and TÜV Rheinland LGA Products GmbH

    Norgine BV

    Manufacturer
    🇳🇱 Netherlands·15 Basic UDI-DIs·15 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    Spierings Orthopaedics B.V.

    Manufacturer
    🇳🇱 Netherlands·19 Basic UDI-DIs·72 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.

    Vertex-Dental B.V.

    Manufacturer
    🇳🇱 Netherlands·30 Basic UDI-DIs·51 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

    RELEGS BV

    Manufacturer
    🇳🇱 Netherlands·3 Basic UDI-DIs·3 Devices·Kiwa Dare B.V.

    Phlecs B.V.

    Manufacturer
    🇳🇱 Netherlands·1 Basic UDI-DI·1 Device·DEKRA Certification B.V.