BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED

    Reg #: 3027694073 · FEI: 3027694073 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED
    Registration Number
    3027694073
    FEI Number
    3027694073
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5Vsip II Street No 7, Viet Nam-Singapore II Industrial Zone, Binh Duon -Urban-Service Industrial Complex Area, Hoa Phu Ward
    City
    Thu Dau Mot Binh Duong
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K190054

    Owner / Operator

    Firm Name
    TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED
    Operator Number
    10094482
    Address
    5Vsip II Street No 7, Viet Nam-Singapore II Industrial Zone, Binh Duon -Urban-Service Industrial Complex Area, Hoa Phu Ward
    City
    Thu Dau Mot
    State
    Binh Duong
    Postal Code
    820000
    Country
    VN
    Correspondent
    Jack Wang

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Pad, Heating, Powered IRT
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    QIDILA 1ml/cc Disposable Syringe with 31G 1/4" (6mm) Needle QIDILA 1ml/cc Disposable Syringe with 30G 5/16" (8mm) Needle QIDILA 1ml/cc Disposable Syringe with 31G 5/16" (8mm) Needle YVTYVT U-100 1ml/cc Syringe with 30G 5/16" (8mm) Needle YVTYVT U-100 1ml/cc Syringe with 31G 5/16" (8mm) Needle QIDILA 1ml/cc Disposable Syringe with 30G 1/2" (12.7mm) Needle YVTYVT U-100 1ml/cc Syringe with 31G 1/4" (6mm) Needle QIDILA 1ml/cc Disposable Syringe with 29G 1/2" (12.7mm) Needle YVTYVT U-100 1ml/cc Syringe with 29G 1/2" (12.7mm) Needle YVTYVT U-100 0.5ml/cc Syringe with 30G 5/16" (8mm) Needle

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)