BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.

    Reg #: 3017619536 · FEI: 3017619536 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    5

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    Registration Details

    Registration Name
    SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
    Registration Number
    3017619536
    FEI Number
    3017619536
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    A1-2nd and A2-4th Floor of Factory Building, No.87 of Hengping Road, Baoan Community, Yuanshan Street, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213884

    Owner / Operator

    Firm Name
    Shenzhen Changke Connect Electronics Co., Ltd.
    Operator Number
    10078314
    Address
    A1-2nd and A2-4th Floor of Factory Building, No.87 of Hengping Road, Baoan Community, Yuanshan Street, Longgang District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518115
    Country
    CN
    Correspondent
    Shunliang Duan

    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
    Electrode, Cutaneous GXY
    Blood Pressure Cuff DXQ
    Cable, Electrode IKD
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Disposable EEG electrode (P01-001-00566; EEG electrode, Disp, 48IN, set of 10) Disposable EEG electrode (P01-001-00576; EEG electrode, Disp, 96IN, 20 sets of 14) Disposable EEG electrode (P01-001-00577; EEG electrode, Disp 120IN, 20 sets of 14) Disposable EEG electrode (P01-001-00567; EEG electrode, Disp, 72IN, set of 14) Disposable EEG electrode (P01-001-00574; EEG electrode, Disp, 48IN, 20 sets of 10) Disposable EEG electrode (P01-001-00569; EEG electrode, Disp, 120IN, set of 14) Disposable EEG electrode (P01-001-00568; EEG electrode, Disp, 96IN, set of 14) Disposable EEG electrode (P01-001-00575; EEG electrode, Disp, 72IN, 20 sets of 14) Disposable NIBP Cuff (model: CK-XT-88062-001, CK-XT-88062-003, CK-XT-88062-007, CK-XT-88062-008, CK-XT-88062-010) Disposable NIBP Cuff (model: CK-XT-88062-005) Generic Snap Connector Cable (model: P01-001-00578, P01-001-00564, P01-001-00562, P01-001-00563) Cable,Snap Connector,Disposable,96IN, 2.44m (Model: P01-001-00571) Cable,Snap Connector,Disposable,120IN, 35m (Model: P01-001-00572) Cable,Snap Connector,Disposable,72IN, 1.83m (Model: P01-001-00570) Disposable ECG Cable (model: CK-SMD-12C4-03A6) ECG Cable (model: P01-001-00565) ECG Lead, Disposable, 72IN, 1.83m (Model: P01-001-00573) Reusable NIBP Cuff (model: CK-XT-78211-001, CK-XT-78211-003, CK-XT-78211-005, CK-XT-78211-006, CK-XT-78211-007) Reusable NIBP Cuff (model: CK-XT-78211-008, CK-XT-78243-000, CK-XT-78243-001, CK-XT-78243-003, CK-XT-78243-005) Reusable NIBP Cuff (model: GCF1200, GCF1202, GCF1203, GCF1204, GCF1205, CK-XT-78243-007, CK-XT-78243-008) Disposable Temperature Probe (model: CK-TP-882111-611D, CK-TP-882121-611D) ECG Cable (model: CK-SMD-481A1-12AR2, CK-SMD-582A1-03AR2, CK-SMD-A82A1-03AN2, CK-SMD-582A1-05AR2, CK-SMD-982A1-05AR2) ECG Cable (model: CK-SMD-980A1-05IR2, CK-SMD-980A1-05AR2) ECG Cable (model: CK-SMD-582A1-03AN2, CK-SMD-480A1-12AR2) ECG Cable (model: P01-001-00545)

    Establishment Types

    Manufacture Medical Device