BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    BK Medical 8809

    Reg #: 3009196578 · FEI: 3009196578 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LBN MEDICAL A/S
    Registration Number
    3009196578
    FEI Number
    3009196578
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gugvej 70
    City
    Aalborg Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K132335

    Owner / Operator

    Firm Name
    LBN Medical ApS
    Operator Number
    10055731
    Address
    Gugvej 70
    City
    Aalborg
    State
    Nordjylland
    Postal Code
    9210
    Country
    DK
    Correspondent
    Jesper K Nielsen

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    BK Medical 8809 BK Medical 8823 BK Medical 8870 BK Medical Flex Focus 400

    Establishment Types

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