BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN MEDKE TECHNOLOGY CO., LTD.

    Reg #: 3012804266 · FEI: 3012804266 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SHENZHEN MEDKE TECHNOLOGY CO., LTD.
    Registration Number
    3012804266
    FEI Number
    3012804266
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    401, 503, Bldg. A1, Anle Ind. Zone, No.172, Hangcheng RD, Sanwei Community, Hangcheng Street, Baoan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K152390

    Owner / Operator

    Firm Name
    Shenzhen Medke Technology Co., Ltd.
    Operator Number
    10053289
    Address
    401, 503, Bldg. A1, Anle Ind. Zone, No.172, Hangcheng RD, Sanwei Community, Hangcheng Street, Baoan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518126
    Country
    CN
    Correspondent
    Zuyin Xian

    US Agent

    Business Name
    Dynasty Medical Consulting Inc.
    Contact Name
    Linda Chen
    Address
    302 Round Lake Dr
    City
    Rosenberg
    State
    TX
    ZIP
    77469
    Country
    US
    Email
    [email protected]
    Phone
    832 3809688

    Products

    Device Name Product Code
    Oximeter DQA
    Blood Pressure Cuff DXQ
    Cable, Electrode IKD
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Medke Spo2 sensor, P8119, P9119, P8325A, P8310F Medke SpO2 Sensor, P9115S, P9318E, P9318H, P9325A, P9310F, P9119A, P8119A, P8115F, P8325A, P8310F NIBP CUFFS ECG Cables (model: G312AMD-B, G512DT, G311NK, G5143DT) ECG Cables (model: G511AA-MB, G511SL-M, G512PH-M, G511DR-6P, G511PH-M, G512DN, G511PH-M, G511MD-M, G511AA, G512DT) Medke Reusable Temperature Probe, T1306, T2306, T3306, T4306 Medke Disposable Temperature Probe, T5106, T6106

    Establishment Types

    Manufacture Medical Device