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Merit Medical Systems, Inc.

USA · South Jordan UT · meritoem.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN US-MF-000001366

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥47, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥47UDI-DI device records

Class I 5Class IIa 21Class IIb 5Class III 16

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

123listed device types

Class I 44Class II 76Class III 2unclassified 1

plus 305 registration records and 187 510(k), 5 PMA

UKUnited KingdomMHRA PARD

107registered device records

Class I 34Class IIa 36Class IIb 14Class III 18Custom-made - Class IIa 1System or Procedure Pack 4

BRBrazilANVISA

162registered devices

Class I 28Class II 134

199 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

38active device licences

Class II 15Class III 3Class IV 20

198 including historic records

TWTaiwanTFDA

44valid device licences

Class I 5Class II 38Class III 1

SGSingaporeHSA SMDR

68device registrations

CLASS B 39CLASS C 11CLASS D 18

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

97active ARTG entries

Class I 7Class III 32IIa 27IIb 16Class Is (sterile) 15

HKHong KongMDACS

71valid listings

Class II 36Class III 12Class IV 23

ILIsraelAMAR

41registrations

RURussiaRoszdravnadzor

36active registrations

Class 1 1Class 2a 16Class 2b 8Class 3 11

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union618 raw hits, 253 excluded, 47 confirmed. Large result set — only the first 300 verified

United States305 registration records, 187 510(k), 5 PMA, 17 excluded

United Kingdom107 confirmed, 2 excluded

Brazil162 confirmed, 2 excluded

Canada38 confirmed, 2 excluded

Manufacturer names merged into this page: MERIT MEDICAL SYSTEMS, INC. · Merit Medical Systems, Inc. · MERIT MEDICAL SYSTEMS, INC · MERIT MEDICAL SYSTEMS INC. · MERIT MEDICAL SYSTEM, INC · MERIT MEDICAL SYSTEMS

Regulatory identity

EU manufacturer SRN: US-MF-000001366
EU authorised representative: Merit Medical Ireland Ltd
UK responsible person: Merit Medical UK Limited

FDA 510(k) clearances by year

52007

32008

62009

42010

42011

62012

102013

132014

82015

72016

132017

82018

42019

72020

72021

42022

82023

42024

72025

42026

FDA listed device types

showing 8 of 123

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) 1Peripheral Catheter Insertion Kit 1Cystoscope And Accessories, Flexible/Rigid 1Prosthesis, Esophageal 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Absorbable Lung Biopsy Plug 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00884450619391	Performa®	Class III
EU	00884450449288	SCOUT®	Class I
EU	00884450839737	Performa®	Class III
EU	00884450795705	Merit Medical®	Class IIa
UK	10688	Performa®	Class IIa
UK	10688	.Impress	Class III
UK	10688	Cathter for Worley ™.CS VERTEBRAL	Class III
US	K261310	FlexTract Deflectable-Rotational Dilator Sheath Set	2026-07-27
US	K262086	PreludeSYNC Radial Compression Device	2026-07-22
US	K254073	StatSeal Disc	2026-05-13
BR	80740950035	Bainha Introdutora Prelude ACT	Class II
BR	80740950072	SwiftNinja Microcateter Dirigível	Class II
BR	80740950107	Extensor de alta pressão em poliuretano Merit	Class II
CA	8675	SAFE SHEATH	Class II
CA	75760	H.LEE SAFESHEATH DIALYSIS INTRODUCER FOR VENOUS ACCESS	Class II
CA	106181	SCOUT SURGICAL GUIDANCE SYSTEM	Class II