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Merit Medical Ireland , Ltd.

Ireland · Galway Galway

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 3 overseas markets. 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

pendingnot queried

USUnited StatesFDA openFDA

32listed device types

Class I 14Class II 18Class III 0

plus 61 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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.

United States61 registration records, 7 510(k), 0 PMA, 20 excluded

Brazil0 confirmed, 8 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: MERIT MEDICAL IRELAND, LTD

FDA 510(k) clearances by year

12012 · K122321

12023 · K221782

12025 · K251181

42026 · K261640

FDA listed device types

showing 8 of 32

Electrosurgical, Cutting & Coagulation & Accessories 1Mechanical Thrombolysis Catheter 1Catheter, Continuous Flush 1Probe, Radiofrequency Lesion 1Endoscopic Guidewire, Gastroenterology-Urology 1Arthroscope 1Wire, Guide, Catheter 1Stylet, Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261640	Merit MAK Nitinol/Gold-Tungsten Guide Wire	2026-07-13
US	K254137	InQwire Amplatz Guide Wire	2026-05-22
US	K253847	Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)	2026-01-31

Merit Medical Ireland , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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