BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    NExT Station

    Reg #: 3001687738 · FEI: 3001687738 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    EB NEURO S.P.A.
    Registration Number
    3001687738
    FEI Number
    3001687738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Bologna 1
    City
    Arbizzano di Valpolicella Verona
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K242832

    Owner / Operator

    Firm Name
    EB NEURO, S.P.A.
    Operator Number
    9043444
    Address
    VIA PIETRO FANFANI 97/A, --
    City
    FLORENCE
    State
    IT-NOTA
    Postal Code
    50127
    Country
    IT
    Correspondent
    Christiano - Pineider

    US Agent

    Business Name
    THEMA CORP
    Contact Name
    Silvia Tamarri
    Address
    2929 Arch Street
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US
    Email
    [email protected]
    Phone
    215 8459459

    Products

    Device Name Product Code
    Electromyograph, Diagnostic IKN
    Stimulator, Auditory, Evoked Response GWJ
    Amplifier, Physiological Signal GWL
    Stimulator, Electrical, Evoked Response GWF
    Stimulator, Photic, Evoked Response GWE
    Non-Normalizing Quantitative Electroencephalograph Software OLT

    Proprietary Names

    NExT Station NExT Station Advanced

    Establishment Types

    Manufacture Medical Device