BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Hologic Selenia Dimensions 3D Mammo

    Reg #: 3008833258 · FEI: 3008833258 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TROMP MEDICAL BV
    Registration Number
    3008833258
    FEI Number
    3008833258
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oude Haarlemmerweg 75
    City
    Castricum Noord-Holland
    Country
    NL

    Regulatory Submissions

    PMA Number
    P080003

    Owner / Operator

    Firm Name
    Tromp Medical
    Operator Number
    10092743
    Address
    Oude Haarlemmerweg 75
    City
    Castricum
    State
    Noord-Holland
    Postal Code
    1901 ND
    Country
    NL
    Correspondent
    Roderik Wondergem

    Products

    Device Name Product Code
    Digital Breast Tomosynthesis OTE

    Proprietary Names

    Hologic Selenia Dimensions 3D Mammo

    Establishment Types

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