BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Vaginal Dilator

    Reg #: 3003968049 · FEI: 3003968049 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Bioteque Taiwan Ltd.
    Registration Number
    3003968049
    FEI Number
    3003968049
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7F., No. 431,433, Baozhang Rd.
    City
    Xizhi Dist., New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K130273

    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
    Correspondent
    Yi-Chien Huang

    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
    Dilator, Vaginal HDX

    Proprietary Names

    Vaginal Dilator

    Establishment Types

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