BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    GEKO W-2

    Reg #: 3016670292 · FEI: 3016670292 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GWALIA HEALTHCARE LIMITED
    Registration Number
    3016670292
    FEI Number
    3016670292
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    TAFFS MEAD ROAD, TREFOREST INDUSTRIAL ESTATE
    City
    PONTYPRIDD Wales
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K193045

    Owner / Operator

    Firm Name
    GWALIA HEALTHCARE LIMITED
    Operator Number
    10063423
    Address
    TAFFS MEAD ROAD, TREFOREST INDUSTRIAL ESTATE
    City
    PONTYPRIDD
    State
    Wales
    Postal Code
    CF375TF
    Country
    GB
    Correspondent
    Vicki Griffiths

    US Agent

    Business Name
    Heyer Regulatory Solutions
    Contact Name
    Sheila Hemeon-Heyer
    Address
    125 Cherry Lane, Amherst
    City
    Amherst
    State
    MA
    ZIP
    01002
    Country
    US
    Email
    [email protected]
    Phone
    413 3308578

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    GEKO W-2

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)