# Shenzhen Gwode Technology Co., Ltd (repackager or relabeler, Shenzhen Guangdong, CN): 1 new FDA device listing, incl. spirometer, therapeutic (incentive)

**Score:** 40/100

| Field | Value |
|---|---|
| Establishment | Shenzhen Gwode Technology Co., Ltd |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 1 |
| Devices | Spirometer, Therapeutic (Incentive) |
| Product codes | BWF |
| Device classes | Class II |
| Medical specialties | Anesthesiology |
| Brand names | INCENTIVE SPIROMETER |
| First new listing | 2026-05-28 |
| Latest new listing | 2026-05-28 |
| FDA registration number | 3043709871 |
| 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: 2026-11-04T21:52:36.524Z.
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.