BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    HDSES01

    Reg #: 3025341449 · FEI: 3025341449 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HJY SMART MEDICAL DEVICE CO., LTD.
    Registration Number
    3025341449
    FEI Number
    3025341449
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12F, No. 415, Sec. 4, Xinyi Rd., Xinyi Dist.
    City
    Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K222735

    Owner / Operator

    Firm Name
    HJY Smart Medical Device Co., Ltd.
    Operator Number
    10086523
    Address
    12F, No. 415, Sec. 4, Xinyi Rd., Xinyi Dist.
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    11051
    Country
    TW
    Correspondent
    John Chen

    Products

    Device Name Product Code
    Endoscope, Neurological GWG

    Proprietary Names

    HDSES01 HDSE201

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility