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GE HealthCare

✓ Record-verifiedregistrations found in 12 marketsUnified social credit code 91310000607327827A

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

100listed device types

Class I 17Class II 83Class III 0

plus 690 registration records and 264 510(k), 55 PMA

UKUnited KingdomMHRA PARD

69registered device records

Class I 12Class IIa 23Class IIb 34

BRBrazilANVISA

30registered devices

Class I 5Class II 25

96 including historic records

SASaudi ArabiaSFDA

64registered imported devices

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

CACanadaMDALL

104active device licences

Class II 44Class III 60

224 including historic records

TWTaiwanTFDA

33valid device licences

Class I 7Class II 26

SGSingaporeHSA SMDR

76device registrations

CLASS B 46CLASS C 30

KRSouth KoreaMFDS GMP

13GMP quality-system certificates

Import 13

AUAustraliaTGA ARTG

86active ARTG entries

Class I 33IIa 21IIb 32

HKHong KongMDACS

16valid listings

Class II 10Class III 6

ILIsraelAMAR

17registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 1Class 2a 7Class 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.

European Union101,266 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States690 registration records, 264 510(k), 55 PMA, 70 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom69 confirmed, 604 excluded

Brazil30 confirmed, 22 excluded

Saudi Arabia64 confirmed, 10 excluded

Canada104 confirmed, 17 excluded

Manufacturer names merged into this page: GE Healthcare Coils · GE HEALTHCARE · GE Healthcare Japan Corporation · Wipro GE Healthcare Private Ltd. · GE HEALTHCARE CANADA INC. · GE HEALTHCARE FINLAND OY

Regulatory identity

UK responsible person: GE Medical Systems Limited
Unified social credit code: 91310000607327827A
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1995-01-27
Registered capital: USD 88,100,000
Paid-in capital: USD 1,100,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Retail trade
Last approval date: 2026-03-10

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

92007

112008

82009

82010

262011

202012

212013

102014

142015

132016

102017

132018

72019

122020

102021

132022

82023

32024

12025

32026

FDA listed device types

showing 8 of 100

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 1Oximeter, Tissue Saturation 1Interventional Fluoroscopic X-Ray System 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	37654	SIGNA Artist	Class IIa
UK	37654	SIGNA Creator	Class IIa
UK	40749	1.5T 4CH Large Flex Coil	Class IIa
US	K253686	True Definition DL	2026-03-23
US	K253738	3.0T AIR 32CH HNA	2026-01-23
US	K253639	View	2026-01-08
BR	80071269021	Sistema de Imagem por Ressonância Magnética	Class II
BR	80071269015	Sistema de Imagem por Ressonância Magnética	Class II
BR	80071269013	Sistema de Imagem por Ressonância Magnética	Class II
SA	ME0000009149SFDAA00001	ECG Leadwire Set	—
SA	ME0000009148SFDAA00001	DIN Converter	—
CA	7071	AMERCHECK	Class II
CA	13933	ADVANTX DLX	Class III
CA	13935	ADVANTX SFX 15I TABLE, SPOT FILM DEVICE SYSTEM	Class III