BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Neural Navigator

    Reg #: 3014251656 · FEI: 3014251656 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    BRAIN SCIENCE TOOLS BV
    Registration Number
    3014251656
    FEI Number
    3014251656
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bunnikseweg 39
    City
    De Bilt Utrecht
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K191422

    Owner / Operator

    Firm Name
    Brain Science Tools BV
    Operator Number
    10078672
    Address
    Bunnikseweg 39
    City
    De Bilt
    State
    Utrecht
    Postal Code
    3732HV
    Country
    NL
    Correspondent
    Manuela Mench

    US Agent

    Business Name
    SOTERIX Medical
    Contact Name
    DENIS ARCE
    Address
    1480 US 9N, 204
    City
    Woodbridge
    State
    NJ
    ZIP
    07095
    Country
    US
    Email
    [email protected]
    Phone
    888 9908327

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW
    Stimulator, Electrical, Evoked Response GWF
    Transcranial Magnetic Stimulator OBP
    Electromyograph, Diagnostic IKN

    Proprietary Names

    Neural Navigator

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198