BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    BIOTEQ Drainage Catheter Set (Seldinger Type)

    Reg #: 3012480535 · FEI: 3012480535 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOTEQUE CORP.
    Registration Number
    3012480535
    FEI Number
    3012480535
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5F-6, No.23, Sec.1, Chang-An E. Rd.
    City
    Taipei
    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
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Nephrostomy, General & Plastic Surgery GBO

    Proprietary Names

    BIOTEQ Drainage Catheter Set (Seldinger Type) MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set

    Establishment Types

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