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Zimmer MedizinSysteme GmbH

Germany · Neu-Ulm · www.zimmer.de

✓ Record-verifiedregistrations found in 12 marketsEU SRN DE-MF-000006141

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 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

13UDI-DI device records

Class IIa 13

USUnited StatesFDA openFDA

15listed device types

Class I 2Class II 13Class III 0

plus 22 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class IIa 9

BRBrazilANVISA

4registered devices

Class II 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 3Class III 1

25 including historic records

TWTaiwanTFDA

14valid device licences

Class II 11Class III 3

SGSingaporeHSA SMDR

10device registrations

CLASS B 9CLASS C 1

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

18active ARTG entries

IIa 18

HKHong KongMDACS

9valid listings

Class II 9

ILIsraelAMAR

18registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 1Class 2a 7Class 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.

European Union13 raw hits, 0 excluded, 13 confirmed

United States22 registration records, 13 510(k), 0 PMA, 2 excluded

United Kingdom9 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: ZIMMER MEDIZINSYSTEME GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000006141
UK responsible person: Trimbio Ltd

Business registration

LEI: 529900FBG6R05NNAIN12
Registration status: Active
Legal form: Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated: 2003-05-27
Registration authority: Commercial Register, no. HRB 6785
Registry record updated: 2025-11-27

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12016

22019

12021

22022

32023

22024

12025

12026

FDA listed device types

showing 8 of 15

Lamp, Infrared, Therapeutic Heating 1Stimulator, Muscle, Powered 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Electrode, Cutaneous 1Massager, Vacuum, Radio Frequency Induced Heat 1Interferential Current Therapy 1Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat 1Stimulator, Muscle, Powered, For Muscle Conditioning 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04053815003618	—	Class IIa
EU	04053815055297	easy air	Class IIa
EU	04053815044550	—	Class IIa
EU	04053815071808	ECG Top BT	Class IIa
UK	58762	emfieldPro, StimSure, ZfieldDual	Class IIa
UK	47790	EndoPuls, enPuls	Class IIa
UK	47790	enPuls Pro	Class IIa
US	K253408	CoolTone	2026-01-16
US	K251378	CoolTone	2025-07-14
US	K240347	PTG-05	2024-07-21
BR	80380269027	Z-TONE	Class II
BR	80380269019	Z-WAVE FAMILY	Class II
BR	80380269022	Cryo 7	Class II
CA	84557	SOLEO GALVA ELECTROTHERAPEUTIC DEVICE	Class II
CA	84558	THERAPY ELECTRODE	Class II
CA	84559	SOLEO SONO ULTRASOUND THERAPY DEVICE	Class II