BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    KUNG SHIN PLASTICS CO., LTD.

    Reg #: 3004116032 · FEI: 3004116032 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    KUNG SHIN PLASTICS CO., LTD.
    Registration Number
    3004116032
    FEI Number
    3004116032
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1F., No. 61, Jia 5th St., Yingge Dist.
    City
    NEW TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K032878

    Owner / Operator

    Firm Name
    Kung Shin Plastics Co., Ltd.
    Operator Number
    9053835
    Address
    1F., No. 61, Jia 5th St., Yingge Dist.
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    239003
    Country
    TW

    US Agent

    Business Name
    ROC Chinese-European Industrial Research Society
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Accessories, Catheter KGZ
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Filter, Bacterial, Breathing-Circuit CAH

    Proprietary Names

    KUNG SHIN SAYKIA VARIOUS MODEL O KUNG SHIH

    Establishment Types

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