BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COOPERVISION, INC.

    Reg #: 1314956 · FEI: 1314956 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    COOPERVISION, INC.
    Registration Number
    1314956
    FEI Number
    1314956
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    711 NORTH RD.
    City
    SCOTTSVILLE
    State
    NY
    ZIP
    14546
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032873
    PMA Number
    P080011

    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

    Products

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

    Proprietary Names

    BIOFINITY XR BIOFINITY MULTIFOCAL BIOFINITY TORIC Biofinity Biofinity Energys Biofinity XR Toric Biofinity XR Multifocal BIOFINITY TORIC MULTIFOCAL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device