BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SOMATEX Medical Technologies GmbH

    Reg #: 3014090621 · FEI: 3014090621 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SOMATEX Medical Technologies GmbH
    Registration Number
    3014090621
    FEI Number
    3014090621
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Blankenfelder Dorfstrasse 94
    City
    Blankenfelde-Mahlow Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K182082

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Sue Dahlquist

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd, Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Marker, Radiographic, Implantable NEU
    Needle, Tumor Localization MIJ

    Proprietary Names

    Tumark for Brevera Tumark Vision Tumark for Eviva TuLoc TuLoc Premium TuFlex Premium TuFlex Tumark Q Tumark Professional Tumark Professional Q-Shape Tumark Professional Q

    Establishment Types

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