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GE MEDICAL SYSTEMS SCS

France · Buc

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, 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

19listed device types

Class I 4Class II 14Class III 1

plus 124 registration records and 41 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

11 including historic records

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

13active device licences

Class II 5Class III 8

36 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

28device registrations

CLASS B 5CLASS C 23

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

25active ARTG entries

Class I 4IIa 11IIb 9Class Im (measuring) 1

HKHong KongMDACS

4valid listings

Class II 3Class III 1

ILIsraelAMAR

18registrations

RURussiaRoszdravnadzor

9active registrations

Class 2a 2Class 2b 7

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 States124 registration records, 41 510(k), 0 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia9 confirmed, 0 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: GE MEDICAL SYSTEMS SCS · GE MEDICAL SYSTEMS SCS (GEMS SCS) · GE Medical System SCS · GE Medical Systems Scs

FDA 510(k) clearances by year

12008

22009

12011

52012

12013

22014

22016

12017

12018

22019

52020

32021

42022

32023

22024

42025

22026

FDA listed device types

showing 8 of 19

Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Tomography, Computed, Emission 1System, Nuclear Magnetic Resonance Imaging 1System, Simulation, Radiation Therapy 1Full Field Digital, System, X-Ray, Mammographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253770	CardIQ Suite	2026-07-21
US	K260087	Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright	2026-03-24
US	K251199	Allia Moveo	2025-12-09
BR	80071260382	DoseWatch	Class I
BR	80071260370	SenoIris	Class II
BR	80071260131	ESTAÇÃO DE TRABALHO AW	Class II
SA	ME0000009143SFDAA00003	DoseWatch	—
SA	ME0000003337SFDAA00023	STATORIX	—
CA	13104	ADVANTX LCV+ ANGIOGRPHIC SYSTEM	Class III
CA	13877	ADVANTX LCN+ ANGIOGRAPHIC SYSTEM	Class III
CA	13923	SENOVISION	Class III

GE MEDICAL SYSTEMS SCS

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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