BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN CAREWELL ELECTRONICS CO., LTD.

    Reg #: 3010089768 · FEI: 3010089768 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    SHENZHEN CAREWELL ELECTRONICS CO., LTD.
    Registration Number
    3010089768
    FEI Number
    3010089768
    Status
    Active
    Expiry Year
    2026
    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
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301
    City
    Bellingham
    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 electrocardiogram ECG-1112M

    Establishment Types

    Manufacture Medical Device