BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biofinity

    Reg #: 2640128 · FEI: 3002911336 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COOPERVISION Manufacturing Puerto Rico, LLC
    Registration Number
    2640128
    FEI Number
    3002911336
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 ROAD 584, LOT 7, AMUELAS INDUSTRIAL PARK
    City
    Juana Diaz
    State
    PR
    ZIP
    00795
    Country
    US

    Regulatory Submissions

    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, Extended Wear LPM

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device