Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010288146

FEI Number

3010288146

Entity Name

Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

702/704,BlockC,Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District, Shenzhen Guangdong 518057, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen BelterHealthMeasurementAndAnalysisTechnology CoLtd (Owner Number: 10043131)

Owner / Operator Contact Address

702/704,BlockC,TsinghuaUnisScience Park, No.13LangshanRd,Hi-TechIndustrialPark(N), Nanshan District, Shenzhen, CN-GD 518057, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-07-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-04-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-02-05
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2020-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shenzhen BelterHealthMeasurementAndAnalysisTechnology CoLtd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010288146. Last updated year: 2026. Please use registration number 3010288146 when referencing this establishment in official correspondence.