# Steris Tomoe Singapore PTE Ltd (contract sterilizer, Singapore South West, SG): 10 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Steris Tomoe Singapore PTE Ltd |
| Owner / operator | Synergy Health AST, LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Singapore South West, SG |
| New listings | 10 |
| Devices | Ureteroscope And Accessories, Flexible/Rigid; Dislodger, Stone, Flexible; Endoscopic Access Overtube, Gastroenterology-Urology; Bronchoscope (Flexible Or Rigid); Electrode, Electrosurgical, Active, Urological; Cystoscope And Accessories, Flexible/Rigid |
| Product codes | FGB, FGO, FED, EOQ, FAS, FAJ |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Ear, Nose, Throat |
| Brand names | InnovexMed (SG) - Flexible Ureterorenoscope; InnovexMed (SG) - Urological Stone Extraction Baskets; InnovexMed (SG) - Ureteral Access Sheaths; InnovexMed (SG) - Flexible Bronchoscope; InnovexMed (SG) - Flexible Cystoscope |
| First new listing | 2026-05-27 |
| Latest new listing | 2026-09-09 |
| FDA registration number | 3010421104 |
| 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: 2026-10-28T20:51:27.468Z.
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.