BEUDAMED
    FDA Registration Active 🇨🇳 China

    DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD

    Reg #: 3017424877 · FEI: 3017424877 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD
    Registration Number
    3017424877
    FEI Number
    3017424877
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4th floor, building D, Yizhong Science Park, 83 Jinsha 2nd Road, Shuikou village, Dalang Town, Dongguan City,
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230642

    Owner / Operator

    Firm Name
    Dongguan kangweile Electronic Technology Co., Ltd
    Operator Number
    10083307
    Address
    4th floor, building D, Yizhong Science Park, 83 Jinsha 2nd Road, Shuikou village, Dalang Town, Dongguan City,
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523770
    Country
    CN
    Correspondent
    Zhixin Gao

    US Agent

    Business Name
    SUN LUNA STAR LLC
    Contact Name
    Anna Sun
    Address
    6706 N Royce Ln
    City
    Van Nuys
    State
    CA
    ZIP
    91411
    Country
    US
    Email
    [email protected]
    Phone
    626 2005096

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Electronic Blood Pressure MonitorKWL-W01.KWL-W02.KWL-W03.KWL-W06.KWL-W08.KWL-W09.KWL-W01L Electronic Blood Pressure MonitorKWL-W01. Electronic Blood Pressure MonitorKWL-B118.KWL-B106 Electronic Blood Pressure Monitor (Arm Type) KWL-B01.KWL-B02.KWL-B03.KWL-B04.KWL-B05.KWL-B06.KWL-B07.KWL-B08.KWL-B09 Electronic Blood Pressure Monitor (Arm Type) KWL-B112.KWL-B168.KWL-B01L.KWL-B116.KWL-B606.KWL-B808.KWL-B698.KWL-B816 Electronic Blood Pressure MonitorKWL-B619.KWL-B13.KWL-B15.KWL-B18.KWL-B17 Electronic Blood Pressure Monitor (Arm Type) KWL-818.KWL-819.KWL-B819L.KWL-B21L.KWL-B22L.KWL-819L

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device