# Sterigenics US LLC (contract sterilizer, West Memphis, AR): 4 new FDA device listings, incl. insufflator, laparoscopic

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Sterigenics US LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | West Memphis, AR, US |
| New listings | 4 |
| Devices | Insufflator, Laparoscopic; Laparoscope, General & Plastic Surgery |
| Product codes | HIF, GCJ |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology, Gastroenterology, Urology |
| Brand names | AIRSEAL 12/150MM PORT; AIRSEAL 8/100MM PORT; AIRSEAL 12/100MM PORT; AIRSEAL 5/75MM PORT; AIRSEAL 12/120MM LPI PORT; AIRSEAL 5/100MM PORT; AIRSEAL 5/150MM BLUNT PORT; AIRSEAL 5/120MM PORT |
| First new listing | 2026-06-04 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 3002907620 |
| 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.
- U.S. establishment.

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.