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Ge Medical Systems Israel , Ltd.

Israel · Haifa

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel, 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

13listed device types

Class I 5Class II 8Class III 0

plus 110 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

11active device licences

Class II 4Class III 7

39 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 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 States110 registration records, 13 510(k), 0 PMA, 23 excluded

Brazil4 confirmed, 5 excluded

Canada11 confirmed, 10 excluded

Manufacturer names merged into this page: GE Medical Systems, Israel Ltd. · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE Medical Systems Israel, Functional Imaging · GE MEDICAL SYSTEMS ISRAEL LTD.

Same-named companies — This database also contains companies with near-identical names: Ge Medical System Israel , Ltd., Ge Medical Systems Israel, Ultrasound, Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12008

22009

32010

22012

12014

12024

32025

FDA listed device types

showing 8 of 13

Automated Radiological Image Processing Software 1System, Image Processing, Radiological 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Tomography, Computed, Emission 1Table, Radiographic, Non-Tilting, Powered 1System, Imaging, Pulsed Doppler, Ultrasonic 1System, X-Ray, Tomography, Computed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251153	Aurora	2025-06-12
US	K243605	Aurora	2025-01-17
US	K241350	Clarify DL	2025-01-03
BR	80071260136	Equipamento de Medicina Nuclear - linha NM 600	Class II
BR	80071260328	Estação de Trabalho de Processo e Revisão Xeleris	Class II
BR	80071260124	Sistema de Medicina Nuclear GE Discovery	Class II
CA	8875	VISION	Class II
CA	8877	VISION POWERSTATION	Class II
CA	14455	OPTIMA NX INTERGRATED MULTIDETECTOR IMAGING SYSTEM	Class II

Ge Medical Systems Israel , 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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