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Ge Medical Systems Europe

France · Buc Cedex

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Russia — 6 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

24listed device types

Class I 5Class II 19Class III 0

plus 144 registration records and 330 510(k), 12 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class II 16

24 including historic records

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

22active device licences

Class II 14Class III 8

93 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 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.

United States144 registration records, 330 510(k), 12 PMA, 103 excluded

Brazil16 confirmed, 30 excluded

Saudi Arabia13 confirmed, 14 excluded

Canada22 confirmed, 27 excluded

Manufacturer names merged into this page: GE MEDICAL SYSTEMS, LLC · GE MEDICAL SYSTEMS LLC · GE MEDICAL SYSTEMS LLC. · GE Medical Systems, LLC

FDA 510(k) clearances by year

12007

112008

32009

32010

92011

62012

42013

102014

32015

62016

52017

32018

52019

22020

62021

42022

32023

22024

52025

62026

FDA listed device types

showing 8 of 24

System, Planning, Radiation Therapy Treatment 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1System, X-Ray, Tomography, Computed 1System, Nuclear Magnetic Resonance Spectroscopic 1Coil, Magnetic Resonance, Specialty 1Automated Radiological Image Processing Software 1Radiological Computer Assisted Detection/Diagnosis Software For Fracture 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253808	AIR Recon DL	2026-08-13
US	K253560	Enhanced Boundary for PCCT	2026-06-24
US	K253502	Critical Care Suite with Enteric Tube Positioning AI Algorithm	2026-04-14
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	ME0000003344SFDAA00010	MX Tubes	—
SA	ME0000003344SFDAA00012	Performix Tubes	—
CA	37797	ORTHONE	Class II
CA	36816	DISCOVERY LS PET-CT SCANNER	Class III
CA	65733	DISCOVERY ST16-PET-CT IMAGING SYSTEM	Class III

Ge Medical Systems Europe

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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