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    FDA Registration Active 🇨🇳 China

    Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd

    Reg #: 3010288146 · FEI: 3010288146 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    7

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    Registration Details

    Registration Name
    Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd
    Registration Number
    3010288146
    FEI Number
    3010288146
    Status
    Active
    Expiry Year
    2026
    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
    Computer, Diagnostic, Programmable DQK
    Oximeter DQA
    Dispenser, Solid Medication NXB
    Analyzer, Body Composition, Exempt PUH
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Body Composition MNW

    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 Infrared Ear Thermometer, TE-66, TE-68, TE-79, T30,T9170, eTE-82B4,TE-82,TE-102,TE-107 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 VENDYS-II,MODEL JK-001V, 6000 B B/C Pulse Oximeter, YM201 PILL PLANNER, Model:EQ-HW-PB-200-CR,EQ-HW-PB-250-CR,EQ-HW-PB-270-CR Body Fat Scale,eF-916W, eF-917W,eF-918W, eF-914B4P, eF-918B4PL, eF-712B4, eF-706B4S Body Composition Scale, S- Smart Scale, eF-917WP, Model:eF-919B4,eF-919B4S,eF-919B4P,eF-919B4SP Body Fat Scale,eF-671B4, WW701YF, WW390YF, GN-WA005-199,WW390F,WW390XF,K90, eF-707B4, K70 Body Fat Scale,eF-706W,eF-654W,eF-655W,eF-670W,eF-802W,eF-803W,eF-804W,eF-805W,eF-806W,eF-807W Bathroom Scale, EF-651B4,EF-654B4,EF-655B4,EF-670B4,EF-706B4,EF-802B4,EF-803B4 Smart Scale, eF-917B4P, eF-918B4P, eF-918B4SP, eF-804B4P, eF-804B4SP, eF-804B4P-Tuya, eF-916B4S Bathroom Scale,EF-804B4,EF-805B4,EF-806B4,EF-807B4,EF-914B4,EF-915B4,EF-916B4,EF-917B4 Blood Pressure Meter, ePA-46B, PA-46, PA-52, PA-54, IVBPA, T9201,BP2,ePA-13B4, PA-09, ePA-09B4 ePA-10B5 ePA-46B5 BLOOD PRESSURE MONITOR, ePA-08B4,EOC-SBPBT-L Body Fat Scale, SF-371, Koogeek-S1, WW701Y, WW303Y, T9140, T9143 Body Composition Scale, S-3

    Establishment Types

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