Data / Medical devices / China / Guangzhou Daxin Health Technology (Dongguan) Co., Ltd
Guangzhou Daxin Health Technology (Dongguan) Co., Ltd: FDA-registered device maker in Dongguan City Guangdong, China, 4 510(k) clearances
Guangzhou Daxin Health Technology (Dongguan) Co., Ltd is registered with the FDA (registration 3019470217) in Dongguan City Guangdong, China. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3019470217
- Address
- Room 601, Building 3, No. 9, Jinshagang Road 1, Dalang Town, Dongguan City Guangdong, China, 523792
- Owner or operator
- Guangzhou Daxin Health Technology Co., Ltd (10081835)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- May 19, 2021
- Registered through
- 2026
- Brand names listed
- BD-HW-PB-500-AC/YH006, BD-HW-PB-800-AC/YH005, BD-HW-PB-900-AC/YH007, BFS1, Blood Pressure Meter, Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D), Body Composition Scale, CLINICAL ELECTRONIC THERMOMETER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Manufacturer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 23, 2026 | K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | DXN | Substantially Equivalent | Guangzhou Daxin Health Technology Co., Ltd. | accessdata.fda.gov |
| April 25, 2025 | K243082 | Infrared Thermometer | FLL | Substantially Equivalent | Guangzhou Daxin Health Technology Co., Ltd. | accessdata.fda.gov |
| May 8, 2017 | K161938 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | accessdata.fda.gov |
| August 21, 2014 | K140681 | BELTER INFRA-RED EAR THERMOMETER | FLL | Substantially Equivalent | Shenzhen Belter Health Measurement and Analysis TE | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Continuous Measurement Thermometer
- All makers of Massager, Therapeutic, Electric
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Analyzer, Body Composition, Exempt
- All makers of Clinical Electronic Thermometer
Updated July 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.