# Shanghai Hua En Industrial Co Ltd (repackager or relabeler, Shanghai, CN): 7 new FDA device listings, incl. syringe, piston

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Shanghai Hua En Industrial Co Ltd |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Shanghai, CN |
| New listings | 7 |
| Devices | Syringe, Piston; Needle, Hypodermic, Single Lumen; Syringe, Antistick |
| Product codes | FMF, FMI, MEG |
| Device classes | Class II |
| Medical specialties | General Hospital |
| First new listing | 2026-08-28 |
| Latest new listing | 2026-08-28 |
| FDA registration number | 3010147274 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

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.