BEUDAMED
    FDA Registration Active 🇨🇳 China

    Thermometer, TE-93, TE-94, TE-95, TE-96, ITH91, ITH93, TE-97, BTHERM1, TSIR1, TM2000, TM4000

    Reg #: 3010288146 · FEI: 3010288146 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd
    Registration Number
    3010288146
    FEI Number
    3010288146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    702/704,BlockC,Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K140681

    Owner / Operator

    Firm Name
    Shenzhen BelterHealthMeasurementAndAnalysisTechnology CoLtd
    Operator Number
    10043131
    Address
    702/704,BlockC,TsinghuaUnisScience Park, No.13LangshanRd,Hi-TechIndustrialPark(N)
    City
    Nanshan District, Shenzhen
    State
    Guangdong
    Postal Code
    518057
    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

    Thermometer, TE-93, TE-94, TE-95, TE-96, ITH91, ITH93, TE-97, BTHERM1, TSIR1, TM2000, TM4000 ITH94F, EQ-HW-TH-500-BK, BW-HW-HM-100-WT Thermometer, eTE-68B4,EOC-STMBT, TE-90, TE-91, eTE-89B4,EQ-HW-TH-100-PD, EQ-HW-TH-150-DI Infrared Thermometer, TE-109, ITH90, eTE-101B4, BW-HW-TH-101-WT Infrared Ear Thermometer, TE-66, TE-68, TE-79, T30,T9170, eTE-82B4,TE-82,TE-102,TE-107

    Establishment Types

    Manufacture Medical Device