BEUDAMED
    FDA Registration Active 🇨🇳 China

    GUANGDONG YOUKEY MEDICAL CO., LTD.

    Reg #: 3025429169 · FEI: 3025429169 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    GUANGDONG YOUKEY MEDICAL CO., LTD.
    Registration Number
    3025429169
    FEI Number
    3025429169
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 601, Block B, Building 1, B1 District, Hantian Technology City, Nanhai District
    City
    Foshan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K231930

    Owner / Operator

    Firm Name
    GuangDong Youkey Medical Co., Ltd.
    Operator Number
    10086505
    Address
    Unit 601, Block B, Building 1, B1 District, Hantian Technology City, Nanhai District
    City
    Foshan
    State
    Guangdong
    Postal Code
    528203
    Country
    CN
    Correspondent
    Zeyi Hu

    US Agent

    Business Name
    SHARE INFO INC.
    Contact Name
    Clare Ho
    Address
    3557 158th St Flushing, NY
    City
    Flushing
    State
    NY
    ZIP
    11358
    Country
    US
    Email
    [email protected]
    Phone
    929 4102964

    Products

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

    Proprietary Names

    Digital Ultrasonic Diagnostic Imaging System (Model: F6) Pocket Ultrasound System (model: P50, P51, P52, P53, P54, P55, P56)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198