BEUDAMED
    FDA Registration Active 🇨🇳 China

    Infrared Ear Thermometer, model: HTD8208C

    Reg #: 3017493034 · FEI: 3017493034 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Hetaida Technology Co., Ltd.
    Registration Number
    3017493034
    FEI Number
    3017493034
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road,, Liaobu Town, Dongguan City, Guangdong Province
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K180387

    Owner / Operator

    Firm Name
    HeTaiDa Technology Co., Ltd
    Operator Number
    10058025
    Address
    Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road,, Liaobu Town, Dongguan City, Guangdong Province
    City
    DongGuan
    State
    Guangdong
    Postal Code
    523423
    Country
    CN
    Correspondent
    Tom Chen

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Infrared Ear Thermometer, model: HTD8208C Infrared Body Thermometer, model: HTD8220US

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device