BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COOPERVISION INC.

    Reg #: 3005724763 · FEI: 3005724763 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    COOPERVISION INC.
    Registration Number
    3005724763
    FEI Number
    3005724763
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    180 THRUWAY PARK DR.
    City
    W Henrietta
    State
    NY
    ZIP
    14586
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234127
    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
    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia QIT

    Proprietary Names

    Avaira Vitality Toric Avaira Vitality Sphere BIOFINITY XR BIOFINITY MULTIFOCAL BIOFINITY TORIC Biofinity Biofinity Energys Biofinity XR Toric Biofinity XR Multifocal BIOFINITY TORIC MULTIFOCAL iWear Active Pearle Vision 1-day Premium Multifocal MyDay Energys MyDay Multifocal MyDay Toric MyDay Asphere Softmed Breathables Advanced Toric HYDRASOFT XW STANDARD (sphere) HYDRASOFT TORIC XW Clariti 1 Day Clariti 1 Day Multifocal Clariti 1 Day Toric

    Establishment Types

    Repack or Relabel Medical Device