HomeSwitzerlandZimmer Switzerland Manufacturing GmbH

Zimmer Switzerland Manufacturing GmbH

Switzerland · Winterthur
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 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
4510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
21registered devices
Class I 6Class II 15
30 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
67 including historic records
TWTaiwanTFDA
8valid device licences
Class I 2Class II 6
SGSingaporeHSA SMDR
5device registrations
CLASS C 5
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
41active ARTG entries
Class I 18Class III 3IIa 18Class Im (measuring) 1Class Is (sterile) 1
HKHong KongMDACS
4valid listings
Class III 4
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
18active registrations
Class 1 7Class 2a 6Class 2b 1Class 3 4
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 States0 registration records, 4 510(k), 0 PMA, 22 excluded
Brazil21 confirmed, 7 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada2 confirmed, 4 excluded
Manufacturer names merged into this page: ZIMMER SWITZERLAND MANUFACTURING GMBH

Company information

Country
Switzerland
City
Winterthur

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12021 · K212129
12023 · K231114
12024 · K241754
12025 · K253749

Registration details (sample)

MarketIdentifierNameClass / date
USK253749Affixus® Natural Nail® Proximal Humeral System2025-12-12
USK241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate2024-08-15
USK231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System2023-08-09
BR80044689002INSTRUMENTAIS PARA CIRURGIA DE JOELHO BIOMET®Class I
BR80044680383Instrumentais para Artroplastia RevitanClass II
BR80044680384INSTRUMENTAIS PARA ARTROPLASTIA TOTAL DE QUADRILClass II
CA92290STABILIZATION BOLT FOR TARGETING DEVICEClass II
CA92356TISSUE PROTECTION SLEEVEClass II

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