BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Biograph mCT 20 Flow

    Reg #: 3017375271 · FEI: 3017375271 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Scandinavian Medical Solutions A/S
    Registration Number
    3017375271
    FEI Number
    3017375271
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gasvaerksvej 48, 1st Floor
    City
    Aalborg Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K151486

    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
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Biograph mCT 20 Flow

    Establishment Types

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