# Sterigenics Shanghai ETO Ltd. (contract sterilizer, Shanghai, CN): 4 new FDA device listings, incl. gown, surgical

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Sterigenics Shanghai ETO Ltd. |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Shanghai, CN |
| New listings | 4 |
| Devices | Gown, Surgical; Needle, Hypodermic, Single Lumen; Syringe, Piston; Syringe, Antistick |
| Product codes | FYA, FMI, FMF, MEG |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, General Hospital |
| Brand names | Cardinal luer lock syringe with safety needle |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-05-14 |
| FDA registration number | 3007007790 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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: 2026-10-28T20:51:27.468Z.
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.