BEUDAMED
    FDA Registration Active 🇨🇳 China

    WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.

    Reg #: 3016493665 · FEI: 3016493665 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
    Registration Number
    3016493665
    FEI Number
    3016493665
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
    City
    Wuxi Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K243711

    Owner / Operator

    Firm Name
    Wuxi Hisky Medical Technologies Co., Ltd.
    Operator Number
    10062500
    Address
    Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
    City
    Wuxi
    State
    Jiangsu
    Postal Code
    214135
    Country
    CN
    Correspondent
    Ying Duan

    US Agent

    Business Name
    Medwheat Inc
    Contact Name
    Vincent Zhou
    Address
    7900 International Dr #300, Bloomington, MN
    City
    Bloomington
    State
    MN
    ZIP
    55425
    Country
    US
    Email
    [email protected]
    Phone
    612 8062995

    Products

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

    Proprietary Names

    Confocal Microprobe Imaging System iLivTouch

    Establishment Types

    Manufacture Medical Device