Home›Korea, Republic›GE ULTRASOUND KOREA, LTD.

GE ULTRASOUND KOREA, LTD.

Korea, Republic · Seongnam-Si

✓ Record-verifiedregistrations found in 10 markets

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

15listed device types

Class I 3Class II 11Class III 1

plus 242 registration records and 118 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class II 22

23 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

16active device licences

Class III 16

60 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

28device registrations

CLASS B 27CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

9valid listings

Class II 9

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

10active registrations

Class 2a 9Class 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 States242 registration records, 118 510(k), 0 PMA, 32 excluded

Brazil22 confirmed, 3 excluded

Saudi Arabia2 confirmed, 2 excluded

Canada16 confirmed, 2 excluded

Manufacturer names merged into this page: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC · GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC · GE ULTRASOUND KOREA, LTD. · GE VINGMED ULTRASOUND A/S · GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC · GE ULTRASOUND KOREA, LTD

FDA 510(k) clearances by year

22007

32008

32009

22010

12011

12012

32013

32014

52015

92016

42017

102018

42019

152020

52021

92022

92023

72024

102025

82026

FDA listed device types

showing 8 of 15

Automated Radiological Image Processing Software 1System, Image Processing, Radiological 1Densitometer, Bone 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan 1Collimator, Automatic, Radiographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261668	Venue Go	2026-08-07
US	K261835	LOGIQ Focus	2026-07-30
US	K260398	LOGIQ e	2026-05-26
BR	80071269022	Sistema de ultrassom diagnóstico	Class II
BR	80071260419	Invenia Abus Viewer	Class II
BR	80071260364	Sistema de Ultrassom	Class II
SA	ME0000003351SFDAA00024	TEE Cleaning and Storing System	—
SA	ME0000003368SFDAA00014	ECG Leadwire Set	—
CA	3634	ACHILLES PLUS ULTRASONOMETER	Class III
CA	251	EXPERT-XL IMAGING DENSITOMETER	Class III
CA	12216	PIXI BONE DENSITOMETER	Class III

GE ULTRASOUND KOREA, LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies