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Fuji Systems Corporation

Japan · Nishi Shirakawa Gun

✓ 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

8listed device types

Class I 0Class II 8Class III 0

plus 14 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

9 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 3CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 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 States14 registration records, 5 510(k), 0 PMA, 9 excluded

Brazil0 confirmed, 1 excluded

Canada4 confirmed, 3 excluded

Manufacturer names merged into this page: FUJI SYSTEMS CORPORATION, Shirakawa Plant · FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant · FUJI SYSTEMS CORPORATION

FDA 510(k) clearances by year

11993 · K924089

12005 · K051522

22012 · K120781

12022 · K223275

FDA listed device types

Enteroscope And Accessories 1Endoscopic Access Overtube, Gastroenterology-Urology 1Tube, Tracheal (W/Wo Connector) 1Catheter, Percutaneous, Neurovasculature 1Endoscope, Accessories, Narrow Band Spectrum 1Catheter, Retention Type, Balloon 1Catheter, Percutaneous 1Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223275	CELLO II Balloon Guide Catheter	2022-12-09
US	K120781	CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH	2012-08-09
US	K113284	BIOPSY POSITIONER	2012-03-07
CA	63902	WIRE REINFORCED ENDOTRACHEAL TUBE	Class II
CA	68338	ENDOBRONCHIAL BLOCKER TUBE CONNECTOR	Class II
CA	63901	ALL SILICONE BALLOON CATHETER - UROLOGICAL	Class II

Fuji 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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