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GE MEDICAL SYSTEMS (CHINA) CO., LTD.

China · Wuxi

✓ 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

79listed device types

Class I 8Class II 70Class III 1

plus 280 registration records and 342 510(k), 12 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

23registered devices

Class II 23

34 including historic records

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

28active device licences

Class II 14Class III 14

107 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

33device registrations

CLASS B 32CLASS C 1

KRSouth KoreaMFDS GMP

7GMP quality-system certificates

Import 7

AUAustraliaTGA ARTG

9active ARTG entries

Class I 2IIa 6IIb 1

HKHong KongMDACS

10valid listings

Class II 8Class III 2

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

22active registrations

Class 2a 20Class 2b 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 States280 registration records, 342 510(k), 12 PMA, 101 excluded

Brazil23 confirmed, 28 excluded

Saudi Arabia13 confirmed, 14 excluded

Canada28 confirmed, 26 excluded

Manufacturer names merged into this page: GE MEDICAL SYSTEMS, LLC · GE MEDICAL SYSTEMS (CHINA) CO., LTD. · GE MEDICAL SYSTEMS LLC · GE MEDICAL SYSTEMS (CHINA) CO. LTD. · GE MEDICAL SYSTEMS (CHINA) CO, LTD. · GE MEDICAL SYSTEMS LLC.

FDA 510(k) clearances by year

12007

112008

52009

52010

102011

72012

72013

122014

42015

62016

62017

32018

52019

22020

62021

42022

32023

22024

52025

62026

FDA listed device types

showing 8 of 79

Detector And Alarm, Arrhythmia 1System, Planning, Radiation Therapy Treatment 1Index-Generating Electroencephalograph Software 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Oximeter, Ear 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 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 (CHINA) CO., LTD.

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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