BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    BIOTEQUE CORP.

    Reg #: 3012480535 · FEI: 3012480535 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    BIOTEQUE CORP.
    Registration Number
    3012480535
    FEI Number
    3012480535
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5F-6, No.23, Sec.1, Chang-An E. Rd.
    City
    Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K251019

    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
    Device, Intravascular Catheter Securement KMK
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Nephrostomy LJE
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Device, Cystometric, Hydraulic FEN
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Catheters, Suction, Tracheobronchial BSY
    Pack, Hot Or Cold, Disposable IMD
    Laparoscopic Accessories, Gynecologic NWV
    Tube, Smoke Removal, Endoscopic FCZ
    System, Gastrointestinal Motility (Electrical) FFX
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC

    Proprietary Names

    TUB500: Tubing, Pump, Infusion line; TUB101: Tubing, Measurement; CATHETERS, SUCTION, TRACHEOBRONCHIAL PACK, HOT OR COLD, DISPOSABLE Trocar Cleaning Swab TUBE, SMOKE REMOVAL, ENDOSCOPIC MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set Tubing/tubing with filter, insufflation, laparoscopic

    Establishment Types

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