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Ge Medical Systems, Inc.

USA · Waukesha

✓ 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

114listed device types

Class I 21Class II 91Class III 2

plus 872 registration records and 745 510(k), 16 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

46registered devices

Class I 3Class II 43

91 including historic records

SASaudi ArabiaSFDA

55registered imported devices

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

CACanadaMDALL

151active device licences

Class II 64Class III 87

419 including historic records

TWTaiwanTFDA

22valid device licences

Class I 5Class II 16未分级 1

SGSingaporeHSA SMDR

38device registrations

CLASS B 16CLASS C 22

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

27active ARTG entries

Class I 5IIa 11IIb 11

HKHong KongMDACS

17valid listings

Class II 6Class III 11

ILIsraelAMAR

36registrations

RURussiaRoszdravnadzor

25active registrations

Class 2a 6Class 2b 19

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 States872 registration records, 745 510(k), 16 PMA, 55 excluded

Brazil46 confirmed, 15 excluded

Saudi Arabia55 confirmed, 7 excluded

Canada151 confirmed, 16 excluded

Manufacturer names merged into this page: GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. · GE HANGWEI MEDICAL SYSTEMS CO., LTD. · GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. · GE Medical Systems Information Technologies, Inc. · GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

FDA 510(k) clearances by year

92007

232008

162009

102010

182011

192012

182013

182014

102015

192016

182017

162018

142019

272020

162021

252022

192023

192024

252025

182026

FDA listed device types

showing 8 of 114

System, Network And Communication, Physiological Monitors 1System, Planning, Radiation Therapy Treatment 1Display, Cathode-Ray Tube, Medical 1Spirometer, Monitoring (W/Wo Alarm) 1Radiological Computer Assisted Detection/Diagnosis Software For Fracture 1Table, Radiographic, Non-Tilting, Powered 1System, Simulation, Radiation Therapy 1Oximeter, Tissue Saturation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253808	AIR Recon DL	2026-08-13
US	K261668	Venue Go	2026-08-07
US	K261835	LOGIQ Focus	2026-07-30
BR	80071260348	Sistema Signa. Modelo: Signa PET/MR	Class II
BR	80071260389	Sistema de Ultrassom Venue	Class II
BR	80071269019	Sistema de Imagem por Ressonância Magnética	Class II
SA	ME0000009150SFDAA00001	NIBP HOSE	—
SA	ME0000009150SFDAA00002	CLASSIC CUF	—
CA	3634	ACHILLES PLUS ULTRASONOMETER	Class III
CA	251	EXPERT-XL IMAGING DENSITOMETER	Class III
CA	12216	PIXI BONE DENSITOMETER	Class III