BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    WISE Cortical Strip

    Reg #: 3030387292 · FEI: 3030387292 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    WISE S.p.A.
    Registration Number
    3030387292
    FEI Number
    3030387292
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Michelangelo Buonarroti 38
    City
    Cologno Monzese Lombardy
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K221123

    Owner / Operator

    Firm Name
    WISE S.p.A
    Operator Number
    10089558
    Address
    Via Michelangelo Buonarroti 38
    City
    Cologno Monzese
    State
    Lombardy
    Postal Code
    20093
    Country
    IT

    US Agent

    Business Name
    QA/RA Consulting Group, Inc.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Road
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Electrode, Cortical GYC

    Proprietary Names

    WISE Cortical Strip

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device