BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    GELFLEX LABORATORIES

    Reg #: 9680540 · FEI: 1000426389 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    GELFLEX LABORATORIES
    Registration Number
    9680540
    FEI Number
    1000426389
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    52 MULGUL ROAD MALAGA
    City
    PERTH Western Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K030027

    Owner / Operator

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

    US Agent

    Business Name
    EyeReg Consulting Inc
    Contact Name
    Bret Andre
    Address
    3762 Landis St
    City
    West Linn
    State
    OR
    ZIP
    97068
    Country
    US
    Email
    [email protected]
    Phone
    503 3725226

    Products

    Device Name Product Code
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, (Disposable) MVN

    Proprietary Names

    Lumenis Synergy, Gelflex Gamma, Delta. Alpha Phantasee, Maxvue Hydrosoft, Dimple, Flash, Sofclear

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198