# STERIS Corporation de Republica Dominicana, S.R.L. (contract sterilizer, Santo Domingo, DO): 3 new FDA device listings, incl. applicator, absorbent tipped, sterile

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | STERIS Corporation de Republica Dominicana, S.R.L. |
| Owner / operator | Synergy Health AST, LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Santo Domingo, DO |
| New listings | 3 |
| Devices | Applicator, Absorbent Tipped, Sterile; System, X-Ray, Mammographic; Instrument, Biopsy |
| Product codes | KXG, IZH, KNW |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Radiology, Gastroenterology, Urology |
| First new listing | 2026-07-15 |
| Latest new listing | 2026-08-17 |
| FDA registration number | 3017636737 |
| Registration expires | 2027-12-31 |

## 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: 2026-11-04T21:52:36.524Z.
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.
