BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Bioteque Corporation I-Lan Factory II

    Reg #: 3004207966 · FEI: 3004207966 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    Bioteque Corporation I-Lan Factory II
    Registration Number
    3004207966
    FEI Number
    3004207966
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.5 Chung Cheng Rd.
    City
    Su-Ao Cheng Yilan
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K210419

    Owner / Operator

    Firm Name
    BIOTEQUE CORP
    Operator Number
    9038266
    Address
    5F-6, NO.23, SEC.1, CHANG-AN E. ROAD
    City
    TAIPEI
    State
    TW-TPE
    Postal Code
    104
    Country
    TW
    Correspondent
    WILLIAM - LEE

    Products

    Device Name Product Code
    Forceps, Ophthalmic HNR
    Device, Intravascular Catheter Securement KMK
    Device, Cystometric, Hydraulic FEN
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Prism, Gonioscopic HKS
    Lens, Condensing, Diagnostic HJL
    Catheters, Suction, Tracheobronchial BSY

    Proprietary Names

    TUB500: Tubing, Pump, Infusion line; TUB101: Tubing, Measurement; MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set CATHETERS, SUCTION, TRACHEOBRONCHIAL

    Establishment Types

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