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SAMSUNG ELECTRONICS CO., LTD.

Korea, Republic · Suwon-Si

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, 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

9listed device types

Class I 2Class II 7Class III 0

plus 42 registration records and 46 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

3active device licences

Class II 3

14 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

14device registrations

CLASS B 6CLASS C 8

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

IIa 3IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

14active registrations

Class 2a 9Class 2b 5

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 States42 registration records, 46 510(k), 0 PMA, 8 excluded

Brazil3 confirmed, 3 excluded

Canada3 confirmed, 3 excluded

Manufacturer names merged into this page: SAMSUNG ELECTRONICS CO., LTD. · Samsung Electronics Co., Ltd. · Samsung Electronics Co., Ltd. Mobile eXperience Business · SAMSUNG ELECTRONICS CO., LTD. Mobile eXperience Business AR · SAMSUNG ELETRONICS CO., LTD · SAMSUNG ELECTRONICS CO LTD.

FDA 510(k) clearances by year

42013

52014

72015

32016

42017

82018

22020

22021

42022

12023

42024

22026

FDA listed device types

showing 8 of 9

Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Photoplethysmograph Analysis Software For Over-The-Counter Use 1Over-The-Counter Device To Assess Risk Of Sleep Apnea 1Electrocardiograph Software For Over-The-Counter Use 1System, X-Ray, Stationary 1Analyzer, Medical Image 1Sunglasses (Non-Prescription Including Photosensitive) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261187	Hearing Aid Feature	2026-07-31
US	K261011	Sleep Apnea Feature (v2.0)	2026-07-20
US	K242651	GM85	2024-10-01
BR	81549250019	SAMSUNG HEALTH MONITOR - Sleep Apnea Feature	Class II
BR	81549259006	SAMSUNG HEALTH MONITOR - ECG APP	Class II
BR	81549259004	SAMSUNG HEALTH MONITOR - BP APP	Class II
CA	91021	GC80 DIAGNOSTIC X-RAY SYSTEM	Class II
CA	91022	XGEO GU60 DIAGNOSTIC X-RAY SYSTEM	Class II
CA	94183	GM60A DIGITAL MOBILE X-RAY IMAGING SYSTEM	Class II

SAMSUNG ELECTRONICS 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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