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Inomed Medizintechnik GmbH.

Germany · Emmendingen

✓ 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

10listed device types

Class I 0Class II 10Class III 0

plus 11 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class II 19

21 including historic records

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

0active device licences

13 including historic records

TWTaiwanTFDA

11valid device licences

Class I 3Class II 8

SGSingaporeHSA SMDR

6device registrations

CLASS B 3CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

16active ARTG entries

Class I 2Class III 2IIa 10IIb 2

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States11 registration records, 10 510(k), 0 PMA, 2 excluded

Brazil19 confirmed, 0 excluded

Saudi Arabia16 confirmed, 0 excluded

Manufacturer names merged into this page: INOMED MEDIZINTECHNIK GMBH · INOMED MIDIZINTECHNIK GMBH · Inomed Medizintechnik GmbH · inomed Medizintechnik GmbH · Inomed Medizintechnik GmbH.

FDA 510(k) clearances by year

11991

12005

12009

12011

12016

22022

22023

12025

FDA listed device types

showing 8 of 10

Stimulator, Electrical, Evoked Response 1Cable, Electrode 1Stimulator, Photic, Evoked Response 1Electromyograph, Diagnostic 1Accelerator, Linear, Medical 1Tube, Tracheal (W/Wo Connector) 1Stimulator, Auditory, Evoked Response 1Neurological Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242852	ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)	2025-06-13
US	K233292	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress	2023-10-27
US	K223254	C2 Xplore	2023-01-27
BR	81963419012	Cânulas Descartáveis	Class II
BR	81086970037	Eletrodo adesivo de laringe	Class II
BR	81895419001	C2 Xplore	Class II
SA	ME0000015179SFDAA00046	Grid/TES Stimulation matrix	—
SA	ME0000015179SFDAA00050	SEP Stimulation Adaptor for ISIS Neurostimulator	—