BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Symbia T16

    Reg #: 3014134519 · FEI: 3014134519 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    FLEXRAY MEDICAL
    Registration Number
    3014134519
    FEI Number
    3014134519
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Speditorvej 19
    City
    Aalborg Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K200474

    Owner / Operator

    Firm Name
    FLEXRAY MEDICAL
    Operator Number
    10057092
    Address
    Speditorvej 19
    City
    Aalborg
    State
    Nordjylland
    Postal Code
    9000
    Country
    DK
    Correspondent
    Mads Vittrup

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Symbia T16

    Establishment Types

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