# Merit Medical Australia Pty Ltd. (foreign exporter, Braiside Victoria, AU): 6 new FDA device listings, incl. dilator, vessel, for percutaneous catheterization

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Merit Medical Australia Pty Ltd. |
| Owner / operator | Merit Medical Systems, Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Braiside Victoria, AU |
| New listings | 6 |
| Devices | Dilator, Vessel, For Percutaneous Catheterization; Unit, Cryosurgical, Accessories; Endoscopic Access Overtube, Gastroenterology-Urology; Endoscopic Irrigation/Suction System; Catheter, Embolectomy |
| Product codes | DRE, GEH, FED, OCX, DXE |
| Device classes | Class II |
| Medical specialties | Cardiovascular, General, Plastic Surgery, Gastroenterology, Urology |
| Brand names | Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; C2 Cryoballoon Ablation System; Sidecar External Working Channel (FG-1011); C2 Cryoballoon Endogrip; Needle's Eye Snare Retrieval Set |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-08-20 |
| FDA registration number | 3033589330 |
| Registration expires | 2027-12-31 |

## Why this score
- 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.