BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    CORELEADER BIOTECH CO., LTD

    Reg #: 3009317711 · FEI: 3009317711 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    CORELEADER BIOTECH CO., LTD
    Registration Number
    3009317711
    FEI Number
    3009317711
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K111733

    Owner / Operator

    Firm Name
    Coreleader Biotech Co., Ltd
    Operator Number
    10040141
    Address
    19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist.
    City
    New Taipei
    State
    TW-NWT
    Postal Code
    22102
    Country
    TW
    Correspondent
    Teeming Tsao

    Products

    Device Name Product Code
    Elastomer, Silicone, For Scar Management MDA
    Dressing, Wound, Drug FRO
    Wound Dressing With Animal-Derived Material(S) KGN
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY

    Proprietary Names

    Scar-D Colla-Algi Algi-Paster Hydro-Healer Colla-Pad Hemo-Pad Bios King Algi-Fiber Algi-Pad

    Establishment Types

    Manufacture Medical Device