Merit Medical Asia Company Limited (foreign exporter, Tsim Sha Tsui, HK): 6 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology
Merit Medical Asia Company Limited (Tsim Sha Tsui): 6 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology. Its amount of 6 is above the median of 2 (88th percentile). Dated 77 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 6 · 88th percentile of 2,709 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 33 related HK DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 88th of 2,709 (median 2, 3.0x median) |
| Peer records CSV (34 HK records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-20
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (HK first): Soher Med Limited (foreign exporter, Hong Kong, HK) · Soher Med Limited (foreign exporter, Hong Kong, HK) · Worldwide Supplies Limited (foreign exporter, Hong Kong, HK) · Worldwide Supplies Limited (foreign exporter, Hong Kong, HK) · Yizur Ltd (foreign exporter, Hong Kong, HK) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Merit Medical Asia Company Limited and 34 HK peers
- HK DeviceEstablishmentPulse records like this one: 34
- Merit Medical Asia Company Limited's amount: 88th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every HK peer: $6,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Merit Medical Asia Company Limited in Tsim Sha Tsui?
Merit Medical Asia Company Limited (Tsim Sha Tsui, HK), a foreign exporter, added 6 FDA device listings between 2026-05-08 and 2026-08-20.
How does Merit Medical Asia Company Limited compare to other DeviceEstablishmentPulse records?
Its amount of 6 sits in the upper half (88th percentile) of 2,709 records; the median is 2. It is 77 days old; check the official source for later updates before acting.
Merit Medical Asia Company Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Merit Medical Asia Company Limited | Tsim Sha Tsui, HK | 6 | 88th | 2026-08-20 |
| Cbr Enterprise Limited | Hong Kong, HK | 59 | 99th | 2026-10-23 |
| Worldwide Supplies Limited | Hong Kong, HK | 117 | 99th | 2026-10-16 |
| Worldwide Supplies Limited | Hong Kong, HK | 120 | 99th | 2026-10-19 |
Related records
DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment
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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.