BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Boris Platform Diagnostic Ultrasound System

    Reg #: 3012503245 · FEI: 3012503245 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TJ-IMAGING APS
    Registration Number
    3012503245
    FEI Number
    3012503245
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Troldholm 5
    City
    Norresundby Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K030455

    Owner / Operator

    Firm Name
    TJ-imaging ApS
    Operator Number
    10053296
    Address
    Troldholm 5
    City
    Noerresundby
    State
    Nordjylland
    Postal Code
    9400
    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, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Boris Platform Diagnostic Ultrasound System

    Establishment Types

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