Home›Germany›EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

Germany · Berlin

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 7 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class II 1

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

1active device licences

Class II 1

6 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 4

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 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 States7 registration records, 8 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

FDA 510(k) clearances by year

12000

12005

12007

12011

12018

12020

12022

12024

FDA listed device types

showing 8 of 10

Burst Suppression Detection Software For Electroencephalograph 1Transcranial Magnetic Stimulator 1Stimulator, Electrical, Evoked Response 1Electrode, Cutaneous 1Amplifier, Physiological Signal 1Electromyograph, Diagnostic 1Amplitude-Integrated Electroencephalograph 1Neurological Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240575	WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)	2024-11-25
US	K210109	visor2 system	2022-04-08
US	K192889	Neo	2020-01-30
BR	80301139033	nëo	Class II
BR	80301130100	Waveguard	Class I
BR	80301130089	WAVEGUARD	Class I
CA	88780	COGNITRACE	Class II