BEUDAMED
    FDA Registration Active 🇨🇳 China

    Infrared Forehead Thermometer; TH1009N(KFT509), TH1009N-B,TH5001N, TH1110N,TH1009N-C

    Reg #: 3005170249 · FEI: 3005170249 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Shenzhen Dongdixin Technology Co., Ltd.
    Registration Number
    3005170249
    FEI Number
    3005170249
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District,
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K161735

    Owner / Operator

    Firm Name
    SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
    Operator Number
    9073156
    Address
    Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate, Xilixiaobaimang Nanshan District,
    City
    SHENZHEN
    State
    Guangdong
    Postal Code
    518108
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    CHARLES MACK
    Address
    2091 Oak Drive
    City
    Lake Havasu City
    State
    AZ
    ZIP
    86406
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Infrared Forehead Thermometer; TH1009N(KFT509), TH1009N-B,TH5001N, TH1110N,TH1009N-C TH1110N-A

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device