# Integral Sterilization Technology (Shaoxing) Co., Ltd (contract sterilizer, Shaoxing Zhejiang, CN): 10 new FDA device listings, incl. catheter, urethral

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Integral Sterilization Technology (Shaoxing) Co., Ltd |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Shaoxing Zhejiang, CN |
| New listings | 10 |
| Devices | Catheter, Urethral; Catheter, Straight; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Catheter, Urological |
| Product codes | GBM, EZD, FCM, KOD |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| First new listing | 2026-08-20 |
| Latest new listing | 2026-08-20 |
| FDA registration number | 3033919393 |
| 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.