BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEXA100

    Reg #: 1835957 · FEI: 3002340631 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ART OPTICAL CONTACT LENS, INC.
    Registration Number
    1835957
    FEI Number
    3002340631
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3175 3 MILE RD. NW
    City
    Walker
    State
    MI
    ZIP
    49534
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171077

    Owner / Operator

    Firm Name
    ART OPTICAL CONTACT LENS, INC.
    Operator Number
    9034824
    Address
    3175 THREE MILE RD. NW, --
    City
    Walker
    State
    MI
    Postal Code
    49534
    Country
    US
    Correspondent
    Erik Anderson

    Products

    Device Name Product Code
    Lens, Contact (Other Material) - Daily HQD
    Lens, Contact (Orthokeratology) MUW

    Proprietary Names

    HEXA100

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)