BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    PERFIT

    Reg #: 3011500388 · FEI: 3011500388 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMILDEN BIOTECHNOLOGY CO., LTD.
    Registration Number
    3011500388
    FEI Number
    3011500388
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7F, NO.186, Jian 1st Rd.,, Chung Ho District
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K133071

    Owner / Operator

    Firm Name
    Smilden Biotechnology CO., Ltd.
    Operator Number
    10091129
    Address
    7F, NO.186, Jian 1st Rd.,, Chung Ho District
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    23553
    Country
    TW
    Correspondent
    Luisa Sam

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    PERFIT

    Establishment Types

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