BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Gelflex Gama (hioxifilcon B)

    Reg #: 9680540 · FEI: 1000426389 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GELFLEX LABORATORIES
    Registration Number
    9680540
    FEI Number
    1000426389
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    52 MULGUL ROAD MALAGA
    City
    PERTH Western Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K024003

    Owner / Operator

    Firm Name
    GELFLEX LABORATORIES
    Operator Number
    9009649
    Address
    52 Mulgul Road Malaga
    City
    Perth
    State
    Western Australia
    Postal Code
    6090
    Country
    AU

    US Agent

    Business Name
    Gelflex USA
    Contact Name
    John Hagendorf
    Address
    100 Reserve Rd, STE C4-183
    City
    Danbury
    State
    CT
    ZIP
    06810
    Country
    US
    Email
    [email protected]
    Phone
    203 7308700

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Gelflex Gama (hioxifilcon B) Gelflex Delta (methafilcon A) 55% Gelflex Alpha (polymacon) 38%

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device