Merit Medical UK Limited (foreign exporter, Earley Reading, GB): 6 new FDA device listings, incl. catheter, embolectomy

Merit Medical UK Limited (Earley Reading): 6 new FDA device listings, incl. catheter, embolectomy. 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: 70 related GB DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentMerit Medical UK Limited
Owner / operatorMerit Medical Systems, Inc.
RoleForeign exporter
Establishment typesExport Device to the United States But Perform No Other Operation on Device
LocationEarley Reading, GB
New listings6
DevicesCatheter, Embolectomy; Endoscopic Irrigation/Suction System; Unit, Cryosurgical, Accessories; Endoscopic Access Overtube, Gastroenterology-Urology; Dilator, Vessel, For Percutaneous Catheterization
Product codesDXE, OCX, GEH, FED, DRE
Device classesClass II
Medical specialtiesCardiovascular, Gastroenterology, Urology, General, Plastic Surgery
Brand namesNeedle's Eye Snare Retrieval Set; C2 Cryoballoon Endogrip; C2 Cryoballoon Ablation System; Sidecar External Working Channel (FG-1011); Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.
First new listing2026-05-08
Latest new listing2026-08-20
FDA registration number3015309643
Registration expires2027-12-31
amount percentile88th of 2,709 (median 2, 3.0x median)
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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

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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 UK Limited and 71 GB peers

  • GB DeviceEstablishmentPulse records like this one: 71
  • Merit Medical UK Limited's amount: 88th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every GB peer: $14,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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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 UK Limited in Earley Reading?

Merit Medical UK Limited (Earley Reading, GB), a foreign exporter, added 6 FDA device listings between 2026-05-08 and 2026-08-20.

How does Merit Medical UK 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 UK Limited vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Merit Medical UK LimitedEarley Reading, GB688th2026-08-20
Kash Sales Inc.Richmond Hill Ontario, CA890th2026-10-16
Imperial Optical, IncTown Of Mount Royal, Quebec, CA377th2026-10-22
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited SirketiCankaya Ankara, TR992nd2026-10-17

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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.

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