# Merit Medical Ireland, Ltd (contract manufacturer, Galway Galway(County), IE): 5 new FDA device listings, incl. dilator, vessel, for percutaneous catheterization

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Merit Medical Ireland, Ltd |
| Owner / operator | Merit Medical Systems, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Galway Galway(County), IE |
| New listings | 5 |
| Devices | Dilator, Vessel, For Percutaneous Catheterization; Wire, Guide, Catheter; Catheter, Embolectomy |
| Product codes | DRE, DQX, DXE |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; MAK Nitinol/Gold-Tungsten Guide Wire; Needle's Eye Snare Retrieval Set; InQwire Amplatz (IQA) |
| First new listing | 2026-05-28 |
| Latest new listing | 2026-08-20 |
| FDA registration number | 9616662 |
| 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: 2026-11-04T21:52:36.524Z.
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.