BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SOMATEX Medical Technologies GmbH

    Reg #: 3030927217 · FEI: 3030927217 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SOMATEX Medical Technologies GmbH
    Registration Number
    3030927217
    FEI Number
    3030927217
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kaiserin-Augusta-Allee 112/113
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K201863

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility