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DEPUY (IRELAND) LTD.

Ireland · Ringaskiddy

✓ 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

93listed device types

Class I 52Class II 38Class III 3

plus 269 registration records and 63 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

44registered devices

Class I 35Class II 9

94 including historic records

SASaudi ArabiaSFDA

90registered imported devices

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

CACanadaMDALL

2active device licences

Class II 1Class III 1

132 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

7device registrations

CLASS B 1CLASS C 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

57active ARTG entries

Class I 28Class III 11IIa 10IIb 8

HKHong KongMDACS

13valid listings

Class III 13

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 2b 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 States269 registration records, 63 510(k), 0 PMA, 42 excluded

Brazil44 confirmed, 12 excluded

Saudi Arabia90 confirmed, 5 excluded

Canada2 confirmed, 7 excluded

Manufacturer names merged into this page: DEPUY (IRELAND) · Depuy Ireland UC · DEPUY IRELAND UC · DEPUY (IRELAND) LTD. · DePuy (Ireland) · DePuy Ireland UC

FDA 510(k) clearances by year

22010

12014

12015

22016

12017

12018

42019

72020

72021

102022

92023

102024

32025

52026

FDA listed device types

showing 8 of 93

Template 1Rasp 1Hook, Bone 1Gouge, Surgical, General & Plastic Surgery 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Chisel, Surgical, Manual 1Probe 1Pusher, Socket 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260480	VELYS Robotic-Assisted Solution	2026-06-25
US	K261458	ATTUNE Total Knee System; ATTUNE Cementless Knee System	2026-06-25
US	K260536	Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement	2026-05-15
BR	10132590285	INSTRUMENTOS P.F.C* E SPECIALIST*	Class I
BR	80145901861	Instrumentais Actis	Class I
BR	10132590627	KIT INSTRUMENTAL PARA PROTESE MODULAR DE QUADRILC-STEM*	Class I
SA	ME0000000727SFDAA00060	ATTUNE™ FEMORAL TRIAL POSTERIOR STABILIZED	—
SA	ME0000000727SFDAA00051	ATTUNE™ CONVENTIONAL MEDIALIZED ANATOMIC PATELLA TRIAL	—
CA	11548	SECTOR ACETABULAR COMPONENT	Class III
CA	78618	SURGICAL GLOVE LINERS	Class II