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COOK IRELAND LIMITED

Ireland · Limerick

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

19listed device types

Class I 2Class II 13Class III 4

plus 27 registration records and 34 510(k), 80 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class II 15

38 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

42 including historic records

TWTaiwanTFDA

44valid device licences

Class I 2Class II 42

SGSingaporeHSA SMDR

29device registrations

CLASS B 11CLASS C 14CLASS D 3D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

30active ARTG entries

Class III 2IIa 13IIb 13Class Is (sterile) 2

HKHong KongMDACS

30valid listings

Class II 10Class III 18Class IV 2

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 1Class 2b 5Class 3 1

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 States27 registration records, 34 510(k), 80 PMA, 34 excluded

Brazil15 confirmed, 14 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada4 confirmed, 11 excluded

Manufacturer names merged into this page: COOK IRELAND LTD · COOK IRELAND LTD. · COOK IRELAND LIMITED

FDA 510(k) clearances by year

32005

22006

12007

12008

12009

22010

12011

22012

22013

12014

32016

42017

42018

12019

12021

12022

12023

22024

12026

FDA listed device types

showing 8 of 19

Stent, Iliac 1Stent, Superficial Femoral Artery 1Stent, Superficial Femoral Artery, Drug-Eluting 1Stent, Iliac Vein 1Biopsy Needle 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Prosthesis, Esophageal 1Stent, Ureteral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261274	EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes	2026-07-24
US	K241209	EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)	2024-07-29
US	K233079	Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)	2024-06-14
BR	10212990044	CONJUNTO PARA DRENAGEM NASO-BILIAR	Class II
BR	10212999032	CÂNULA PARA BIÓPSIA EUS ECHOTIP® CLEARCORE	Class II
BR	10212999007	CÂNULA SUPERIOR PARA DIVERTÍCULOS ZENKER	Class II
CA	64429	PRESSURE MEASUREMENT DEVICES	Class II
CA	64524	SENSORS	Class II
CA	66491	STONE EXTRACTION DEVICES	Class II