BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DEHAS Medical Systems GmbH

    Reg #: 3013156250 · FEI: 3013156250 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    DEHAS Medical Systems GmbH
    Registration Number
    3013156250
    FEI Number
    3013156250
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Wesloer Strasse 107-109
    City
    Luebeck Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K103324

    Owner / Operator

    Firm Name
    DEHAS Medical Systems GmbH
    Operator Number
    10043558
    Address
    Wesloer Strasse 107-109
    City
    Luebeck
    State
    Schleswig-Holstein
    Postal Code
    23568
    Country
    DE
    Correspondent
    Jens Meincke

    US Agent

    Business Name
    Draeger Medical Systems, INC.
    Contact Name
    Melissa Gray
    Address
    6 Tech Dr
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 4473613

    Products

    Device Name Product Code
    Flowmeter, Tube, Thorpe, Back-Pressure Compensated CAX
    Tubing, Pressure And Accessories BYX
    Unit, Liquid-Oxygen, Portable BYJ
    Regulator, Pressure, Gas Cylinder CAN
    Mixer, Breathing Gases, Anesthesia Inhalation BZR

    Proprietary Names

    Flowmeter for PM2300er PM2100er Easymate 6, 6+6 PM2200 QualityREG Oxymixer Configuration Oxymixer Low Flow 15LPM Oxymixer High Flow SET Oxymixer Low Flow SET Oxymixer XL Low Flow

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198