BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DermaGold100, model OW100S-US

    Reg #: 3005462245 · FEI: 3005462245 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MTS Medical AG
    Registration Number
    3005462245
    FEI Number
    3005462245
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROBERT-BOSCH-STRASSE 18, ROBERT-BOSCH-STRASSE 9 (Production Facility)
    City
    KONSTANZ Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K231710

    Owner / Operator

    Firm Name
    MTS Medical AG
    Operator Number
    9088139
    Address
    ROBERT-BOSCH-STRASSE 18, ROBERT-BOSCH-STRASSE 9
    City
    KONSTANZ
    State
    Baden-Wurttemberg
    Postal Code
    78467
    Country
    DE
    Correspondent
    Ralph - Reitmajer

    US Agent

    Business Name
    SoftWave Tissue Regeneration Technologies LLC.
    Contact Name
    John Warlick
    Address
    10000 Avalon Blvd Ste 720
    City
    Alpharetta
    State
    GA
    ZIP
    30009
    Country
    US
    Email
    [email protected]
    Phone
    888 8626162

    Products

    Device Name Product Code
    Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers PZL

    Proprietary Names

    DermaGold100, model OW100S-US

    Establishment Types

    Manufacture Medical Device