BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Screine

    Reg #: 1720129 · FEI: 1720129 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OPTIKEM INTERNATIONAL, INC.
    Registration Number
    1720129
    FEI Number
    1720129
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2172 SOUTH JASON ST.
    City
    Denver
    State
    CO
    ZIP
    80223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011561

    Owner / Operator

    Firm Name
    OPTIKEM INTERNATIONAL, INC
    Operator Number
    9917011
    Address
    2172 SOUTH JASON ST., --
    City
    Denver
    State
    CO
    Postal Code
    80223
    Country
    US
    Correspondent
    SALLY A COOK

    Products

    Device Name Product Code
    Lens, Contact (Polymethylmethacrylate) HPX
    Accessories, Soft Lens Products LPN

    Proprietary Names

    Screine

    Establishment Types

    Manufacture Medical Device