# Merit Medical Asia Company Limited (foreign exporter, Tsim Sha Tsui, HK): 6 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Merit Medical Asia Company Limited |
| 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 | Tsim Sha Tsui, HK |
| New listings | 6 |
| Devices | Endoscopic Access Overtube, Gastroenterology-Urology; Unit, Cryosurgical, Accessories; Dilator, Vessel, For Percutaneous Catheterization; Catheter, Embolectomy; Endoscopic Irrigation/Suction System |
| Product codes | FED, GEH, DRE, DXE, OCX |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, General, Plastic Surgery, Cardiovascular |
| Brand names | Sidecar External Working Channel (FG-1011); C2 Cryoballoon Ablation System; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; Needle's Eye Snare Retrieval Set; C2 Cryoballoon Endogrip |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-08-20 |
| FDA registration number | 3015225571 |
| 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.