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SAMSUNG MEDISON CO., LTD.

Korea, Republic · Hongcheon-Gun Gangwon-Do

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

7listed device types

Class I 2Class II 5Class III 0

plus 153 registration records and 73 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

21active device licences

Class II 1Class III 20

48 including historic records

TWTaiwanTFDA

13valid device licences

Class II 13

SGSingaporeHSA SMDR

30device registrations

CLASS B 30

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

6valid listings

Class II 6

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

27active registrations

Class 1 1Class 2a 26

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 States153 registration records, 73 510(k), 0 PMA, 3 excluded

Brazil10 confirmed, 1 excluded

Canada21 confirmed, 1 excluded

Manufacturer names merged into this page: SAMSUNG MEDISON CO., LTD. · SAMSUNG MEDISON CO., LTD (ANTIGA MEDISON CO, LTD) · SAMSUNG MEDISON CO LTD.

FDA 510(k) clearances by year

32011

12012

52013

42014

52015

42016

52017

72018

92019

42020

62021

52022

42023

62024

22025

32026

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Chair, Surgical, Ac-Powered 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261412	V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;	2026-07-28
US	K254099	EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System	2026-03-27
US	K252018	HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System	2026-01-05
BR	81549250017	EQUIPAMENTO DE DIAGNÓSTICO POR ULTRASSOM	Class II
BR	81549259001	EQUIPAMENTO DE DIAGNÓSTICO POR ULTRASSOM	Class II
BR	81549250018	FAMÍLIA DE SOFTWARE PARA ANALISE DE IMAGEM DE ULTRASSOM	Class II
CA	73	ULTRAMARK 400 ULTRASOUND SYSTEM	Class II
CA	67844	SA-9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM	Class III
CA	84907	SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM	Class III

SAMSUNG MEDISON 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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