# Guangzhou Daxin Health Technology (Dongguan) Co., Ltd (manufacturer, Dongguan City Guangdong, CN): 1 new FDA device listing, incl. system, measurement, blood-pressure, non-invasive

**Score:** 60/100

| Field | Value |
|---|---|
| Establishment | Guangzhou Daxin Health Technology (Dongguan) Co., Ltd |
| Owner / operator | Guangzhou Daxin Health Technology Co., Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Dongguan City Guangdong, CN |
| New listings | 1 |
| Devices | System, Measurement, Blood-Pressure, Non-Invasive |
| Product codes | DXN |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | ePA-46B,ePA-46B5,ePA-13B4,PA-09,ePA-09B4; Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) |
| First new listing | 2026-08-01 |
| Latest new listing | 2026-08-01 |
| FDA registration number | 3019470217 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.