# Andersen Caledonia Ltd (contract sterilizer, Bellshill Scotland, GB): 4 new FDA device listings, incl. protector, ostomy

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Andersen Caledonia Ltd |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Bellshill Scotland, GB |
| New listings | 4 |
| Devices | Protector, Ostomy; Instrument, Surgical, Sonic And Accessory/Attachment; Electrosurgical, Cutting & Coagulation & Accessories; Bag, Intestine |
| Product codes | EXE, JDX, GEI, KGY |
| Device classes | Class I, Class II |
| Medical specialties | Gastroenterology, Urology, Orthopedic, General, Plastic Surgery |
| Brand names | ACE Stopper & Dressing; TORS - (T1AH - Single Use Axial-Grip Handpiece (Single Use -Sterile)); Neuromark System; Medicina Silo Bag |
| First new listing | 2026-07-08 |
| Latest new listing | 2026-09-26 |
| FDA registration number | 3004530184 |
| 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.
- Listed in the last 45 days.

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.
