BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ELVATION MEDICAL GMBH

    Reg #: 3009212453 · FEI: 3009212453 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    ELVATION MEDICAL GMBH
    Registration Number
    3009212453
    FEI Number
    3009212453
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Ludwig-Wolf-Str. 6
    City
    Kieselbronn Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K200251

    Owner / Operator

    Firm Name
    ELvation Medical GmbH
    Operator Number
    10042279
    Address
    Ludwig-Wolf-Str. 6
    City
    Kieselbronn
    State
    Baden-Wurttemberg
    Postal Code
    75249
    Country
    DE
    Correspondent
    Frederic Reisser

    US Agent

    Business Name
    ELvation Medical LLC
    Contact Name
    Marco Ruggiero
    Address
    1475 Alderman Drive
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    440 7813622

    Products

    Device Name Product Code
    Table, Operating-Room, Electrical GDC
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    3000950 Mindray Z50 Piezolith 3000 Triple Focus PiezoWave 2 MyACT PiezoWave 2 Touch

    Establishment Types

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