BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Nihon Kohden NKV-330 Ventilator System, model: MSK3313P, MSK3314P, MSK3315P, MSK3316P

    Reg #: 3031369651 · FEI: 3031369651 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HSINER CO., LTD.
    Registration Number
    3031369651
    FEI Number
    3031369651
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 251, Sec.1,Houke Rd., Houli Dist.
    City
    Taichung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K213521

    Owner / Operator

    Firm Name
    HSINER CO., LTD.
    Operator Number
    9053474
    Address
    312, Jhongshang Rd., Shengang Dist.
    City
    Taichung City
    State
    TW-TXG
    Postal Code
    429
    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
    Ventilator, Continuous, Minimal Ventilatory Support, Facility Use MNT

    Proprietary Names

    Nihon Kohden NKV-330 Ventilator System, model: MSK3313P, MSK3314P, MSK3315P, MSK3316P Nihon Kihden Exhalation Port

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)