BEUDAMED
    FDA Registration Active 🇨🇳 China

    Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

    Reg #: 3008457078 · FEI: 3008457078 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
    Registration Number
    3008457078
    FEI Number
    3008457078
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K100626

    Owner / Operator

    Firm Name
    Shenzhen Biocare Bio-Medical Equipment Co., LTD
    Operator Number
    10036523
    Address
    #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518122
    Country
    CN
    Correspondent
    Hongbo Zhong

    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
    Monitor, Ultrasonic, Fetal KNG
    Electrocardiograph DPS

    Proprietary Names

    FM-200 Doppler Fetal Heart Rate Detector Digital Electrocardiograph iE 10 Digital electrocardiograph iE 3, iE 6, iE 12, iE 12A, iE 15, ECG-12l0, ECG-3010 and ECG-6010 Digital Electrocardiograph iE 101 and iE300

    Establishment Types

    Manufacture Medical Device