BEUDAMED
    FDA Registration Active 🇨🇳 China

    QBit Series Diagnostic Ultrasound System

    Reg #: 3004753388 · FEI: 3004753388 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CHISON Medical Technologies Co., Ltd.
    Registration Number
    3004753388
    FEI Number
    3004753388
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.3 Changjiang South Road, Xinwu District, No.9, Xinhuihuan Road, Xinwu District
    City
    WUXI Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150861

    Owner / Operator

    Firm Name
    CHISON Medical Technologies Co., Ltd.
    Operator Number
    9066279
    Address
    No.3 Changjiang South Road, Xinwu District, No.9, Xinhuihuan Road, Xinwu District
    City
    Wuxi
    State
    Jiangsu
    Postal Code
    214028
    Country
    CN
    Correspondent
    RUOLI - MO

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., LTD
    Contact Name
    Marco Mu
    Address
    2219 Rimland Drive, Suite 301, Bellingham, Barkley Villiage
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    QBit Series Diagnostic Ultrasound System D7C10L, D7BC8, V6C10L, D6C15L, D3C20L, D3P64L, D2P64L, D6P64L, D2D16L, T5P64L, MT5P48L Diagnostic Ultrasound Transducer D7L30L, M10L60L,D7L40L-REC,D6C12L, V4C40L, D7C10W,D5C20L, M7C10L Diagnostic Ultrasound Transducer QBit 1/QBit 2/ QBit 3/ QBit 4/QBit 5/QBit 6/QBit 7/QBit 8/QBit 9/ QBit 10/QBit 11/QBit 12 Diagnostic Ultrasound System D3C60L, D5C40L, D3C50L, M3C60L,D7L40L, M7L40L, D7L60L, D12L40L Diagnostic Ultrasound Transducer

    Establishment Types

    Manufacture Medical Device