BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Amplifier Physiological Signal

    Reg #: 3007701713 · FEI: 3007701713 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EMS HANDELS GESELLSCHAFT M.B.H.
    Registration Number
    3007701713
    FEI Number
    3007701713
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Jochingergasse 1
    City
    Korneuburg Niederosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K171397

    Owner / Operator

    Firm Name
    EMS Handels Gesellschaft m.b.H.
    Operator Number
    10055944
    Address
    Jochingergasse 1
    City
    Korneuburg
    State
    Niederosterreich
    Postal Code
    A-2100
    Country
    AT
    Correspondent
    Kristi L Marks

    US Agent

    Business Name
    Smith Rudiger Inc d/b/a Smith Associates
    Contact Name
    Kristi Marks
    Address
    1468 Harwell Ave
    City
    Crofton
    State
    MD
    ZIP
    21114
    Country
    US
    Email
    [email protected]
    Phone
    410 4510639 ext. 203

    Products

    Device Name Product Code
    Amplifier, Physiological Signal GWL
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    Amplifier Physiological Signal

    Establishment Types

    Manufacture Medical Device