BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

    Reg #: 9612389 · FEI: 3003255845 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
    Registration Number
    9612389
    FEI Number
    3003255845
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    GUBENER STR. 47,, FABRIKGEBAEUDE
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K183376

    Owner / Operator

    Firm Name
    EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
    Operator Number
    9042702
    Address
    GUBENER STR. 47,, FABRIKGEBAEUDE
    City
    BERLIN
    State
    DE-NOTA
    Postal Code
    D-10243
    Country
    DE
    Correspondent
    Maarten - van de Velde

    US Agent

    Business Name
    Quality & Regulatory Help, LLC
    Contact Name
    Dana Coggin
    Address
    115 Reeder Street
    City
    Tillamook
    State
    OR
    ZIP
    97141
    Country
    US
    Email
    [email protected]
    Phone
    715 3605401

    Products

    Device Name Product Code
    Transcranial Magnetic Stimulator OBP
    Electrode, Cutaneous GXY
    Full-Montage Standard Electroencephalograph GWQ
    Amplitude-Integrated Electroencephalograph OMA
    Burst Suppression Detection Software For Electroencephalograph ORT
    Reduced- Montage Standard Electroencephalograph OMC
    Electromyograph, Diagnostic IKN
    Neurological Stereotaxic Instrument HAW
    Stimulator, Electrical, Evoked Response GWF
    Amplifier, Physiological Signal GWL

    Proprietary Names

    StimGuide waveguard net eego cognitrace neo monitor neo visor2 system eego amplifier WaveGuard

    Establishment Types

    Manufacture Medical Device