BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Bioteque Taiwan Ltd.

    Reg #: 3003968049 · FEI: 3003968049 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    12
    Establishment Types
    5
    Classifications
    7

    Registration Details

    Registration Name
    Bioteque Taiwan Ltd.
    Registration Number
    3003968049
    FEI Number
    3003968049
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7F., No. 431,433, Baozhang Rd.
    City
    Xizhi Dist., New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K092982

    Owner / Operator

    Firm Name
    Bioteque Taiwan Ltd.
    Operator Number
    10088630
    Address
    7F, No. 431 and 7F, No. 433, Baozhang Rd., Xizhi Dist.
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    221036
    Country
    TW

    US Agent

    Business Name
    Bioteque Amercia Inc.
    Contact Name
    Gary Liu
    Address
    1302 Exchange Drive, Suite 150
    City
    Richardson
    State
    TX
    ZIP
    75081
    Country
    US
    Email
    [email protected]
    Phone
    800 8899008

    Products

    Device Name Product Code
    Curette, Suction, Endometrial (And Accessories) HHK
    Pessary, Vaginal HHW
    Cannula, Manipulator/Injector, Uterine LKF
    Sound, Uterine HHM
    Dilator, Vaginal HDX
    Dilator, Cervical, Fixed Size HDQ
    Instrument, Manual, Specialized Obstetric-Gynecologic KNA

    Proprietary Names

    The Curette and Preferred Curette Flexi Shelf Pessary Uterine Manipulator Injector 4.5 Uterine sound Uterine Injector 2/4 Vaginal Dilator HSG Catheter Set Bellota Sonohysterography Catheter Silicon Inflatable Donut Pessary Cervical Dilator Vaginal Pessary Word/Bartholin Catheter

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)