BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    iWear Active

    Reg #: 3009108089 · FEI: 3009108089 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CooperVision CL KFT
    Registration Number
    3009108089
    FEI Number
    3009108089
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gorcsev Ivan Street 7, Building C
    City
    Gyal Budapest
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K130331

    Owner / Operator

    Firm Name
    COOPERVISION, INC.
    Operator Number
    9929062
    Address
    6101 Bollinger Canyon Road, Suite 500
    City
    San Ramon
    State
    CA
    Postal Code
    94583
    Country
    US

    US Agent

    Business Name
    COOPERVISION, INC.
    Contact Name
    Annette Nelson
    Address
    6101 Bollinger Canyon Road, Suite 500
    City
    San Ramon
    State
    CA
    ZIP
    94583
    Country
    US
    Email
    [email protected]
    Phone
    925 6604471

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, (Disposable) MVN

    Proprietary Names

    iWear Active

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device