Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd
Registered establishment in Shenzhen, Guangdong, China. 7 device types.
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Analyzer, Body Composition and 5 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010288146 |
| FEI number | 3010288146 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 702/704,BlockC,Tsinghua Unis Science Park, No.13 Langshan Rd |
| Postal code | 518057 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Body Composition | Class 2 | Body Composition Scale, S-3, Body Fat Scale, SF-371, Koogeek-S1, WW701Y, WW303Y, T9140, T9143 | 2013 | 11 |
| Analyzer, Body Composition, Exempt | Class 2 | Bathroom Scale,EF-804B4,EF-805B4,EF-806B4,EF-807B4,EF-914B4,EF-915B4,EF-916B4,EF-917B4, Smart Scale, eF-917WP, Model:eF-919B4,eF-919B4S,eF-919B4P,eF-919B4SP, Body Fat Scale,eF-916W, eF-917W,eF-918W, eF-914B4P, eF-918B4PL, eF-712B4, eF-706B4S, Body Fat Scale,eF-706W,eF-654W,eF-655W,eF-670W,eF-802W,eF-803W,eF-804W,eF-805W,eF-806W,eF-807W, Smart Scale, eF-917B4P, eF-918B4P, eF-918B4SP, eF-804B4P, eF-804B4SP, eF-804B4P-Tuya, eF-916B4S, Bathroom Scale, EF-651B4,EF-654B4,EF-655B4,EF-670B4,EF-706B4,EF-802B4,EF-803B4 and 2 more | 2018 | 36 |
| Computer, Diagnostic, Programmable | Class 2 | Vendys-Ii,model JK-001V, 6000 B B/C | 2017 | 10 |
| Continuous Measurement Thermometer | Class 2 | Thermometer, TE-93, TE-94, TE-95, TE-96, ITH91, ITH93, TE-97, BTHERM1, TSIR1, TM2000, TM4000, Infrared Ear Thermometer, TE-66, TE-68, TE-79, T30,T9170, eTE-82B4,TE-82,TE-102,TE-107, Infrared Thermometer, TE-109, ITH90, eTE-101B4, BW-HW-TH-101-WT, 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 | 2015 | 115 |
| Dispenser, Solid Medication | Class 1 | PILL PLANNER, Model:EQ-HW-PB-200-CR,EQ-HW-PB-250-CR,EQ-HW-PB-270-CR | 2020 | 68 |
| Oximeter | Class 2 | Pulse Oximeter, YM201 | 2021 | 70 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Blood Pressure Meter, ePA-46B, PA-46, PA-52, PA-54, IVBPA, T9201,BP2,ePA-13B4, PA-09, ePA-09B4, BLOOD PRESSURE MONITOR, ePA-08B4,EOC-SBPBT-L, ePA-10B5, ePA-46B5 | 2014 | 98 |
Clearances
No clearance names Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K191430 | 2019-10-18 | DQA | Traditional | Shenzhen Yimi Life Technology Co., Ltd. |
| K140681 | 2014-08-21 | FLL | Traditional | Shenzhen Belter Health Measurement and Analysis TE |
| K134029 | 2014-07-25 | DXN | Traditional | Shenzhen Belter Health Measurement and Analysis TE |
| K122976 | 2013-01-04 | MNW | Traditional | Shenzhen Belter Health Measurement and Analysis TE |
| K072919 | 2007-11-02 | DQK | Special | Endothelix, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Employees | 800 |
| Main products | Blood pressure monitors, Digital scales, Thermometers, Health measurement devices |
| Certifications | CE, ISO 9001, ISO 13485, SA8000, FCC, ROHS |
| Export markets | Multiple international markets |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.