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INTEGRA LIFESCIENCES (IRELAND) LIMITED

Ireland · Tullamore

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

435listed device types

Class I 351Class II 72Class III 5unclassified 7

plus 1,391 registration records and 105 510(k), 497 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

72registered devices

Class I 61Class II 11

217 including historic records

SASaudi ArabiaSFDA

93registered imported devices

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

CACanadaMDALL

33active device licences

Class II 16Class III 6Class IV 11

243 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS C 1CLASS D 2

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

34active ARTG entries

Class I 20Class III 1IIa 3IIb 9Class Is (sterile) 1

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

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 States1,391 registration records, 105 510(k), 497 PMA, 18 excluded

Brazil72 confirmed, 8 excluded

Saudi Arabia93 confirmed, 5 excluded

Canada33 confirmed, 6 excluded

Manufacturer names merged into this page: INTEGRA LIFESCIENCES CORPORATION · Integra LifeSciences Corporation · INTEGRA LIFESCIENCES (IRELAND) LIMITED · Integra LifeSciences Production Corporation · INTEGRA LIFESCIENCES CORPORATION DBA INTEGRA NEUROSCIENCES · INTEGRA LIFESCIENCES CORPORATION ALSO DBA INTEGRA NEUROSCIENCES

Same-named companies — This database also contains companies with near-identical names: INTEGRA LIFESCIENCES CORPORATION, Integra LifeSciences Production Corporation, Integra Spine (Integra Lifesciences). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

72007

22008

42009

52010

22011

62012

32013

82014

32015

62016

42017

72018

52019

32020

32021

32022

32023

32024

42025

12026

FDA listed device types

showing 8 of 435

Syringe, Restorative And Impression Material 1Knife, Nasal 1Cannula, Ventricular 1Strip, Adhesive, Closure, Skin 1Instrument, Contouring, Matrix, Operative 1Drill, Dental, Intraoral 1Gag, Mouth 1Tamp 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261004	Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)	2026-06-23
US	K251162	CUSA® Clarity Ultrasonic Surgical Aspirator System	2025-10-08
US	K243531	Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology	2025-08-08
BR	80086380011	INSTRUMENTAIS NÃO ARTICULADOS NÃO CORTANTES VANTAGE	Class I
BR	80086380012	INSTRUMENTAIS ARTICULADOS CORTANTES VANTAGE	Class I
BR	80086380014	INSTRUMENTAIS ARTICULADOS NÃO CORTANTES LINHA CERÂMICA VANTAGE	Class I
SA	ME0000015850SFDAA00107	CODMAN® Bipolar Cord Unitized Plug, Reusable	—
SA	ME0000015850SFDAA00117	CODMAN® EDS 3™ Leveling Device	—
CA	82470	CAMINO PRESSURE MONITORING AND DRAINAGE KITS	Class IV
CA	3661	VENTRICULAR CATHETER INTRODUCER	Class III
CA	3663	SUBCUTANEOUS PERITONEAL CATHETER PASSER	Class II