BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GPE MedTech Systeme GmbH

    Reg #: 3008867836 · FEI: 3008867836 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GPE MedTech Systeme GmbH
    Registration Number
    3008867836
    FEI Number
    3008867836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gewerbestrasse 1
    City
    Dassow Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K072885

    Owner / Operator

    Firm Name
    GPE-Systeme
    Operator Number
    10047011
    Address
    Gewerbestrasse 1
    City
    Dassow
    State
    Mecklenburg-Western Pomerania
    Postal Code
    23942
    Country
    DE
    Correspondent
    Kai Bannicke

    US Agent

    Business Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Contact Name
    John Ferros
    Address
    6 TECH DRIVE
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 4828515

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)