BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MTS Medical AG

    Reg #: 3005462245 · FEI: 3005462245 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MTS Medical AG
    Registration Number
    3005462245
    FEI Number
    3005462245
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ROBERT-BOSCH-STRASSE 18, ROBERT-BOSCH-STRASSE 9 (Production Facility), ROBERT-BOSCH-STRASSE 11 (Purchasing, Incoming goods, Storage)
    City
    KONSTANZ Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K210451

    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
    Tom Rhodes
    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
    Massager, Therapeutic, Electric ISA
    Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers PZL
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS

    Proprietary Names

    OrthoGold100, model OW100-US DermaGold100, model OW100-US Softwave Gold Li DermaGold100, model OW100S-US OW100S, model OW100S-US LITHOGOLD

    Establishment Types

    Manufacture Medical Device