BEUDAMED
    FDA Registration Active 🇨🇳 China

    HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.

    Reg #: 3008754120 · FEI: 3008754120 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.
    Registration Number
    3008754120
    FEI Number
    3008754120
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    298 Yunxi Road, Cangqian Street, Yuhang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K102718

    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
    Clinical Electronic Thermometer SDV

    Proprietary Names

    Renewed Energy, Digital Thermometer, 121811/11012340 Digital Thermometer, Multiple Models VDTS-100U,EDTS-100U,VDTS-100R,VDTS-100B GF-MT501, GF-MT502, GF-MT503, GF-MT504, GF-MT505, GF-MT506, GF-MT507, GF-MT508, GF-MT509 GF-MT101, GF-MT102, GF-MT103, GF-MT104, GF-MT105, GF-MT106, GF-MT107, GF-MT108, GF-MT109 GF-MT801, GF-MT802, GF-MT803 Infrared Thermometer Infrared Forehead Thermometer FT-100C FT-100A FT-100B Digital thermometer Clinical electronic thermometer Infrared ear thermometer, ET-100A, ET-100B, ET-100C, ET-100D, ET-100E Infrared forehead thermometer, FT-100A, FT-100B, FT-100C, FT-100D, FT-100E, FT-100F Infrared ear/forehead thermometer, EF-100A, EF-100B, EF-100C, EF-100D, EF-100E, EF-100F, EF-100G, EF-100H Infrared thermometer Clinical thermometer

    Establishment Types

    Manufacture Medical Device