BEUDAMED
    FDA Registration Active 🇨🇳 China

    Carewell, Model AI-ECG Platform, Programmable Diagnostic Computer

    Reg #: 3010089768 · FEI: 3010089768 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHENZHEN CAREWELL ELECTRONICS CO., LTD.
    Registration Number
    3010089768
    FEI Number
    3010089768
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K180432

    Owner / Operator

    Firm Name
    Shenzhen Carewell Electronics Co., Ltd.
    Operator Number
    10047185
    Address
    Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518108,Shenzhen, P.R. China
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518108
    Country
    CN
    Correspondent
    Yi Zheng

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., Ltd
    Contact Name
    Macro Mu
    Address
    2219 Rimlang Drive, Suite 301 , Bellingham-Barkley Villiage Bakerview, Washington, 98226, UNITED STATES
    City
    Bakerview
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Carewell, Model AI-ECG Platform, Programmable Diagnostic Computer

    Establishment Types

    Manufacture Medical Device