BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    TAIWAN BIOMATERIAL Company, Ltd.

    Reg #: 3014590707 · FEI: 3014590707 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    TAIWAN BIOMATERIAL Company, Ltd.
    Registration Number
    3014590707
    FEI Number
    3014590707
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1F, No. 188, Sec. 1, Shengyi Rd., Zhubei City, Hsinchu County
    City
    Zhubei Hsinchu
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K190105

    Owner / Operator

    Firm Name
    Taiwan Biomaterial Co., Ltd.
    Operator Number
    10058651
    Address
    1F, No. 188, Sec. 1, Shengyi Rd.
    City
    Zhubei
    State
    Hsinchu
    Postal Code
    302058
    Country
    TW
    Correspondent
    Wen-Hsi Wang

    US Agent

    Business Name
    Imperative Care, Inc.
    Contact Name
    Brian Prom
    Address
    1359 Dell Ave
    City
    Campbell
    State
    CA
    ZIP
    95008
    Country
    US
    Email
    [email protected]
    Phone
    408 5027548

    Products

    Device Name Product Code
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Catheter, Thrombus Retriever NRY

    Proprietary Names

    TRUVIC Peripheral Canister Zoom Aspiration Tubing Zoom POD TRUVIC Tubeset Zoom Duoport Canister Zoom Canister TRUVIC Generator Zoom Pump ZOOM Aspiration Tubing

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)