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GE Medical Systems Information Technologies, Inc.

USA · Tampa

✓ 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

58listed device types

Class I 4Class II 54Class III 0

plus 156 registration records and 176 510(k), 4 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 2Class II 6

12 including historic records

SASaudi ArabiaSFDA

32registered imported devices

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

CACanadaMDALL

81active device licences

Class II 40Class III 41

153 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

44device registrations

CLASS B 20CLASS C 24

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

104active ARTG entries

Class I 46IIa 25IIb 33

HKHong KongMDACS

19valid listings

Class II 13Class III 6

ILIsraelAMAR

28registrations

RURussiaRoszdravnadzor

28active registrations

Class 1 3Class 2a 5Class 2b 20

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 States156 registration records, 176 510(k), 4 PMA, 27 excluded

Brazil8 confirmed, 4 excluded

Saudi Arabia32 confirmed, 0 excluded

Canada81 confirmed, 1 excluded

Manufacturer names merged into this page: GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. · GE Medical Systems Information Technologies, Inc. · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES INC. · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC

FDA 510(k) clearances by year

52006

52007

62008

72009

32010

42011

22012

42013

12014

12015

12016

12017

12018

22020

12021

72022

32023

32024

12025

22026

FDA listed device types

showing 8 of 58

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Uterine Electromyographic Monitor 1Index-Generating Electroencephalograph Software 1Amplifier And Signal Conditioner, Transducer Signal 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Oximeter, Ear 1Analyzer, Gas, Oxygen, Gaseous-Phase 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253277	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P	2026-07-24
US	K251670	MAC 7 Resting ECG Analysis System	2026-01-26
US	K242562	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P	2025-07-09
BR	80071260159	CARDIOSOFT	Class II
BR	80071260191	DISPOSITIVO DE INTERFACE (ID) DA REDE UNITY	Class I
BR	80071269014	Sistema de Análise de ECG em Repouso MAC 5	Class II
SA	ME0000009150SFDAA00001	NIBP HOSE	—
SA	ME0000009150SFDAA00002	CLASSIC CUF	—
CA	3309	TRANSCERVICCAL INTRAUTERINE PRESSURE KIT	Class II
CA	3693	MODEL 147	Class II
CA	5789	PH MONITOR	Class II