BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    X3D APS

    Reg #: 3030186509 · FEI: 3030186509 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    X3D APS
    Registration Number
    3030186509
    FEI Number
    3030186509
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Oldenvej 33
    City
    Kvistgaard Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K081829

    Owner / Operator

    Firm Name
    X3D ApS
    Operator Number
    10089603
    Address
    Oldenvej 33
    City
    Kvistgaard
    State
    Hovedstaden
    Postal Code
    3490
    Country
    DK
    Correspondent
    Thomas Nielsen

    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
    Camera, Scintillation (Gamma) IYX
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    CapIMAGE SoloMobile CorCam CARDIO MD CardioMD C.CAM Body MD BodyMD QuantumCam

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device