BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    Sofclear Enhance

    Reg #: 3006406551 · FEI: 3006406551 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PT Gelflex Indonesia
    Registration Number
    3006406551
    FEI Number
    3006406551
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Complex Sarana IND. Point Blok A, JLN ENGKU Putri No,11 Batam Center
    City
    Batam Riau
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K181558

    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
    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
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Sofclear Enhance Sofclear Comfort Sofclear Colors Flash Chromaview Eyeblends Maxvue Hydrosoft Dimple Phantasee Colourvue Chromaview Eyefx Dimple Color Dinple Color

    Establishment Types

    Manufacture Medical Device