BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    UNICON OPTICAL CO., LTD.

    Reg #: 3013170070 · FEI: 3013170070 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    UNICON OPTICAL CO., LTD.
    Registration Number
    3013170070
    FEI Number
    3013170070
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.16, Gongye E. 9th Rd., Hsinchu Science Park, Baoshan Township
    City
    Hsinchu County
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K141917

    Owner / Operator

    Firm Name
    Unicon Optical Co., Ltd.
    Operator Number
    10052876
    Address
    No.16, Gongye E. 9th Rd., Hsinchu Science Park, Baoshan Township
    City
    Hsinchu County
    State
    TW-HSQ
    Postal Code
    30075
    Country
    TW
    Correspondent
    Will Wang

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Unicon (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens To be notified Ivision Qualis Alice Silicone 1-Day Alice Silicone Bi-weekly Soft Contact Lens Alice H.A. Daily Soft Contact Lens

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)