BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Scandinavian Medical Solutions A/S

    Reg #: 3017375271 · FEI: 3017375271 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    Scandinavian Medical Solutions A/S
    Registration Number
    3017375271
    FEI Number
    3017375271
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gasvaerksvej 48, 1st Floor
    City
    Aalborg Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K141477

    Owner / Operator

    Firm Name
    Scandinavian Medical Solutions A/S
    Operator Number
    10077435
    Address
    Gasvaerksvej 48, 1st Floor
    City
    Aalborg
    State
    DK-NOTA
    Postal Code
    9000
    Country
    DK

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Tomography, Computed JAK
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL

    Proprietary Names

    GE Discovery IQ5R Selenia Dimensions Siemens TxRx 15Ch Knee Coil 3T, 10606829 GE Revolution CT Apec Edition 512 Siemens Verio 3T GE MR 450W GE Optima CT660 Siemens CT Force Siemens Biograph Horizon Siemens Inspiration Biograph mCT 20 Flow GE Revolution EVO 128 Siemens Biograph mCT 128 GE Voyager 1.5T Senographe Essential Optima MR430S 1, 5T

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device