BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Enobio Dx 8

    Reg #: 3010762896 · FEI: 3010762896 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    NEUROELECTRICS BARCELONA S.L.U.
    Registration Number
    3010762896
    FEI Number
    3010762896
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Av Tibidabo, 47 Bis
    City
    Barcelona Catalonia
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K162681

    Owner / Operator

    Firm Name
    Neuroelectrics Barcelona, S.L.U.
    Operator Number
    10055170
    Address
    Av Tibidabo, 47 Bis
    City
    Barcelona
    State
    Catalonia
    Postal Code
    08035
    Country
    ES
    Correspondent
    Conxi Verdu

    US Agent

    Business Name
    Neuroelectrics USA Corporation
    Contact Name
    Ana Maiques
    Address
    1 Broadway, 14th floor, united states
    City
    Cambridge
    State
    MA
    ZIP
    02142
    Country
    US
    Email
    [email protected]
    Phone
    617 6820770

    Products

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

    Proprietary Names

    Enobio Dx 8 Enobio Dx 20 Enobio Dx 32

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device