BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GERMAN MEDICAL ENGINEERING GMBH

    Reg #: 3011024620 · FEI: 3011024620 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GERMAN MEDICAL ENGINEERING GMBH
    Registration Number
    3011024620
    FEI Number
    3011024620
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dreikoenigstr. 6-8
    City
    Erlangen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K180518

    Owner / Operator

    Firm Name
    German Medical Engineering GmbH
    Operator Number
    10047245
    Address
    Grimmstrasse 23
    City
    Nuerenberg
    State
    Bavaria
    Postal Code
    90491
    Country
    DE
    Correspondent
    Stefan Schulze

    US Agent

    Business Name
    Bentley Biomedical Consulting, LLC
    Contact Name
    Shepard Bentley
    Address
    28241 Crown Valley Parkway, Suite 510(k)
    City
    Laguna Niguel
    State
    CA
    ZIP
    92677
    Country
    US
    Email
    [email protected]
    Phone
    949 3749187

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Light, Ultraviolet, Dermatological FTC

    Proprietary Names

    LinScan FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm FlexSys IR 1550 nm LinScan System FlexSys Green 532 module FlexSys Yellow 577 module TwinScan 808/755 Laser System ExSys 308 System

    Establishment Types

    Manufacture Medical Device