BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Hologic Selenia Dimensions TOMO

    Reg #: 3009196578 · FEI: 3009196578 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    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
    K123873

    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
    Full Field Digital, System, X-Ray, Mammographic MUE

    Proprietary Names

    Hologic Selenia Dimensions TOMO Hologic Selenia Dimensions 8000

    Establishment Types

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