BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Katalyst Training System

    Reg #: 3016832824 · FEI: 3016832824 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Leader Garment Co., Ltd.
    Registration Number
    3016832824
    FEI Number
    3016832824
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block II-7, Hoa Phu IZ (Stage 2), Hoa Phu Ward, Long Ho District Vinh Long
    City
    Long Ho District Vinh Long
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K190966

    Owner / Operator

    Firm Name
    MAKALOT INDUSTRIAL CO., LTD
    Operator Number
    10068735
    Address
    2F., No.550, Sec. 4, Zhongxiao E. Rd., Xinyi Dist.,, Taipei City 110, Taiwan (R.O.C.)
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    110
    Country
    TW
    Correspondent
    Tzu Yang Chou

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX

    Proprietary Names

    Katalyst Training System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)