BEUDAMED
    FDA Registration Active 🇨🇳 China

    Infrared Forehead Thermometer

    Reg #: 3008754120 · FEI: 3008754120 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.
    Registration Number
    3008754120
    FEI Number
    3008754120
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    298 Yunxi Road, Cangqian Street, Yuhang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160802

    Owner / Operator

    Firm Name
    Hangzhou Universal Electronic Co., Ltd.
    Operator Number
    10034707
    Address
    298 Yunxi Road, Cangqian Street, Yuhang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311121
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Infrared Forehead Thermometer Infrared Thermometer FT-100A FT-100B FT-100C

    Establishment Types

    Manufacture Medical Device