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Olympus Medical Systems Corporation

Japan · Hachioji-Shi

✓ 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

74listed device types

Class I 13Class II 60Class III 0unclassified 1

plus 277 registration records and 187 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

59registered devices

Class I 1Class II 58

70 including historic records

SASaudi ArabiaSFDA

181registered imported devices

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

CACanadaMDALL

68active device licences

Class II 63Class III 5

276 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

86device registrations

CLASS B 72CLASS C 14

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

19active ARTG entries

Class I 9IIa 6IIb 2Class Is (sterile) 2

HKHong KongMDACS

128valid listings

Class II 103Class III 25

ILIsraelAMAR

29registrations

RURussiaRoszdravnadzor

85active registrations

Class 1 3Class 2a 77Class 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 States277 registration records, 187 510(k), 0 PMA, 31 excluded

Brazil59 confirmed, 4 excluded

Saudi Arabia181 confirmed, 3 excluded

Canada68 confirmed, 5 excluded

Manufacturer names merged into this page: OLYMPUS MEDICAL SYSTEMS CORP. · OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant · OLYMPUS MEDICAL SYSTEM CORP. · OLYMPUS MEDICAL SYSTEM CORPORATION · OLYMPUS MEDICAL SYSTEMS CORPORATION · Olympus Medical system Corp.

FDA 510(k) clearances by year

42007

102008

52009

72010

62011

122012

82013

22014

62015

62016

82017

112018

142019

142020

52021

72022

32023

42024

322025

82026

FDA listed device types

showing 8 of 74

Electrosurgical, Cutting & Coagulation & Accessories 1Gastrointesinal Lesion Software Detection System 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Accessories, Cleaning, For Endoscope 1Brush, Biopsy, Bronchoscope (Non-Rigid) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261183	EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)	2026-07-31
US	K254056	THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)	2026-07-01
US	K261260	HD Camera Head OLYMPUS CH-S200-08-LB	2026-06-24
BR	80124630021	VIDEODUODENOSCOPIO	Class II
BR	80124639032	Pinça de apreensão para uso único	Class II
BR	80124639033	Cânula de Imobilização de Uso Único	Class II
SA	ME0000002757SFDAA00001	VISERA ELITE II XENON LIGHT SOURCE	—
SA	ME0000002757SFDAA00002	Visera Elite II Video System Center	—
CA	318	OLYMPUS OES GASTROFIBERSCOPE GIF TYPE AND ACCESSORIES	Class II
CA	337	OLYMPUS EVIS BRONCHOVIDEOSCOPE WITH ACCESSORIES	Class II
CA	436	OLYMPUS OES SIGMOIDOFIBERSCOPE WITH ACCESSORIES	Class II

Olympus Medical Systems Corporation

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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