BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    BE Plus PRO

    Reg #: 9617286 · FEI: 3003208775 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    EB NEURO, S.P.A.
    Registration Number
    9617286
    FEI Number
    3003208775
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA PIETRO FANFANI 97/A
    City
    FLORENCE Tuscany
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K242305

    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
    Full-Montage Standard Electroencephalograph GWQ
    Amplifier, Physiological Signal GWL
    Standard Polysomnograph With Electroencephalograph OLV
    Non-Normalizing Quantitative Electroencephalograph Software OLT

    Proprietary Names

    BE Plus PRO Neurotravel LIGHT

    Establishment Types

    Manufacture Medical Device