BEUDAMED
    FDA Registration Active 🇨🇳 China

    Scan Monitor (ScanWatch, hwa09; ScanWatch 2, hwa10)

    Reg #: 3012404027 · FEI: 3012404027 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    REGENT ELECTRON SUZHOU CO., LTD
    Registration Number
    3012404027
    FEI Number
    3012404027
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.888.Ganquan Dong Road, Economic development zone
    City
    Wujiang Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201456

    Owner / Operator

    Firm Name
    Regent Electron Suzhou Co., Ltd
    Operator Number
    10051810
    Address
    NO.888.Ganquan Dong Road, Economic development zone,
    City
    Wujiang
    State
    Jiangsu
    Postal Code
    215200
    Country
    CN

    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
    Oximeter DQA
    Electrocardiograph DPS
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Scan Monitor (ScanWatch, hwa09; ScanWatch 2, hwa10)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)