BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CUSTOMFLEX ARTIFICIAL IRIS

    Reg #: 3010531293 · FEI: 3010531293 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HUMANOPTICS HOLDING AG
    Registration Number
    3010531293
    FEI Number
    3010531293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Westerwaldstr. 11-13
    City
    Sankt Augustin North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    PMA Number
    P170039

    Owner / Operator

    Firm Name
    HumanOptics Holding AG
    Operator Number
    10058390
    Address
    Westerwaldstr. 11-13
    City
    Sankt Augustin
    State
    North Rhine-Westphalia
    Postal Code
    53757
    Country
    DE
    Correspondent
    Alexander Burka

    US Agent

    Business Name
    Clinical Research Consultants, Inc.
    Contact Name
    Barbara Fant
    Address
    3928 North Cliff Lane
    City
    Cincinnati
    State
    OH
    ZIP
    45220
    Country
    US
    Email
    [email protected]
    Phone
    513 6073932

    Products

    Device Name Product Code
    Artificial Iris QBT

    Proprietary Names

    CUSTOMFLEX ARTIFICIAL IRIS

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)