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    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·MIXED.Industries B.V.·2 devices

    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.

    FDA Enforcement
    Class II ·Terminated·Claymount Assembli·July 9, 2014

    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.

    FDA Enforcement
    Class II ·Terminated·Claymount Assembli·July 9, 2014

    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

    FDA Enforcement
    Class II ·Ongoing·Vital Scientific N.V.·December 4, 2019

    Mobius 3D Technologies

    Manufacturer
    🇳🇱 Netherlands

    2D PERFUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    2D Quantitative Analysis

    FDA 510(k)
    FDA Class 2 ·Radiology

    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.

    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.

    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.

    Medis Medical Imaging Systems bv

    Manufacturer
    🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·SGS Belgium NV and SGS Belgium NV

    DEBx Medical BV

    Manufacturer
    🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·ENTE CERTIFICAZIONE MACCHINE SRL and ENTE CERTIFICAZIONE MACCHINE SRL

    IQ Products BV

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

    Willingsford NL

    Manufacturer
    🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy