BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    geko W-2

    Reg #: 3011197543 · FEI: 3011197543 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FIRSTKIND LTD
    Registration Number
    3011197543
    FEI Number
    3011197543
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Suite 3, St Johns Court, Easton Street
    City
    High Wycombe Buckinghamshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K193045

    Owner / Operator

    Firm Name
    Firstkind Ltd
    Operator Number
    10047447
    Address
    Suite 3, St John's Court, Easton Street
    City
    High Wycombe
    State
    Buckinghamshire
    Postal Code
    HP11 1JX
    Country
    GB
    Correspondent
    Neil Buckley

    US Agent

    Business Name
    Heyer Regulatory Solutions
    Contact Name
    Sheila Hemeon-Heyer
    Address
    125 Cherry Ln
    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

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility