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ZIMMER PTE. LTD.

Singapore · Winterthur

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 9 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

179listed device types

Class I 86Class II 84Class III 7unclassified 2

plus 1,111 registration records and 422 510(k), 145 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

67registered devices

Class I 29Class II 38

130 including historic records

SASaudi ArabiaSFDA

180registered imported devices

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

CACanadaMDALL

91active device licences

Class II 21Class III 70

430 including historic records

TWTaiwanTFDA

59valid device licences

Class I 8Class II 50Class III 1

SGSingaporeHSA SMDR

99device registrations

CLASS B 10CLASS C 89

KRSouth KoreaMFDS GMP

7GMP quality-system certificates

Import 7

AUAustraliaTGA ARTG

1,394active ARTG entries

Class I 1,140Class III 147IIa 54IIb 47Class Im (measuring) 4Class Is (sterile) 2

HKHong KongMDACS

24valid listings

Class II 1Class III 22Class IV 1

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 States1,111 registration records, 422 510(k), 145 PMA, 46 excluded

Brazil67 confirmed, 18 excluded

Saudi Arabia180 confirmed, 6 excluded

Canada91 confirmed, 14 excluded

Manufacturer names merged into this page: ZIMMER PTE. LTD. · ZIMMER GMBH · ZIMMER, INC. · ZIMMER INC. · ZIMMER INC · ZIMMER, INC

FDA 510(k) clearances by year

142007

112008

82009

82010

92011

162012

132013

162014

192015

62016

52017

72018

212019

122020

32021

42022

22023

62024

52025

82026

FDA listed device types

showing 8 of 179

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Electrosurgical, Cutting & Coagulation & Accessories 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Cerclage, Fixation 1Prosthesis, Hip, Femoral, Resurfacing 1Washer, Bolt Nut 1Appliance, Fixation, Spinal Interlaminal 1Prosthesis, Hip, Femoral Component, Cemented, Metal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261683	Augment Off-Axis Instrument System	2026-06-16
US	K260831	Z1 Hip System	2026-06-16
US	K251840	Zimmer® Persona® Personalized Knee System	2026-05-28
BR	10355870046	INSTRUMENTOS ZIMMER AC	Class I
BR	10355870056	Instrumentos Zimmer ANC	Class I
BR	80044680383	Instrumentais para Artroplastia Revitan	Class II
SA	ME0000009005SFDAA00001	repositioning top, 22	—
SA	ME0000009005SFDAA00002	Wagner SL Revision®, tray for base instruments, empty	—
CA	4197	ACETABULAR ROOF REINFORCEMENT RINGS AND CAGES	Class III
CA	10044	PROTASUL UNIPOLAR HEAD	Class III
CA	11093	CLS ACETABULAR SYSTEM	Class III

ZIMMER PTE. 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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