# Shenzhen Huayan E-Commerce Co., Ltd. (foreign exporter, Shenzhen Guangdong, CN): 2 new FDA device listings, incl. oximeter, wellness

**Score:** 40/100

| Field | Value |
|---|---|
| Establishment | Shenzhen Huayan E-Commerce Co., Ltd. |
| Owner / operator | Shenzhen Huayan E-commerce Co., Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 2 |
| Devices | Oximeter, Wellness; Pulse Oximeter For Over-The-Counter Use |
| Product codes | PGJ, OLK |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | Pulse Oximeter For Over-The-Counter Use; OXIMETER, WELLNESS: AW-401 |
| First new listing | 2026-09-08 |
| Latest new listing | 2026-09-08 |
| FDA registration number | 3017953405 |
| Registration expires | 2026-12-31 |

## Why this score
- 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: 2026-10-28T20:51:27.468Z.
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.