BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DORNIER MEDTECH GMBH

    Reg #: 9611388 · FEI: 3002806833 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    26
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    DORNIER MEDTECH GMBH
    Registration Number
    9611388
    FEI Number
    3002806833
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ARGELSRIEDER FELD 7
    City
    WESSLING Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K180350
    PMA Number
    P840008

    Owner / Operator

    Firm Name
    DORNIER MEDTECH GMBH
    Operator Number
    8010622
    Address
    ARGELSRIEDER FELD 7, --
    City
    WESSLING
    State
    Bavaria
    Postal Code
    D82234
    Country
    DE
    Correspondent
    Dietmar - Holzhammer

    US Agent

    Business Name
    DORNIER MEDTECH AMERICA, INC.
    Contact Name
    John Hoffer
    Address
    1155 Roberts Blvd Nw
    City
    KENNESAW
    State
    GA
    ZIP
    30144
    Country
    US
    Email
    [email protected]
    Phone
    770 5146163 ext. 0

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Table, Cystometric, Non-Electric And Accessories KQS
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS

    Proprietary Names

    Urotract OPUS Dornier Medilas D Multibeam Dornier Medilas D Litebeam + Dornier Medilas D30 Laser Dornier Medilas D FlexiPulse Dornier Medilas D Litebeam Diode Family of Lasers Dornier Medilas D60 Laser Dornier Medilas D Urobeam Genesis Gemini Delta III Lithotripter Compact Sigma Lithotripter Compact Alpha Lithotripter MPL Compact Delta Lithotripter MFL HM4 HM3 Gemini XXP-HP Genesis II Gemini 220 XP Medillas Fibertome and Skinpulse Laser DORNIER UROTRACT 1 OPUSII

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device