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FUJIFILM CORPORATION

Japan · Minato-Ku

✓ 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

19listed device types

Class I 3Class II 15Class III 1

plus 43 registration records and 67 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

149registered devices

Class I 26Class II 123

153 including historic records

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

51active device licences

Class II 43Class III 8

113 including historic records

TWTaiwanTFDA

12valid device licences

Class I 2Class II 10

SGSingaporeHSA SMDR

61device registrations

CLASS B 49CLASS C 12

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

75active ARTG entries

Class I 18IVD Class 1 2IVD Class 2 2IIa 43IIb 8Class Is (sterile) 2

HKHong KongMDACS

85valid listings

Class II 73Class III 12

ILIsraelAMAR

22registrations

RURussiaRoszdravnadzor

58active registrations

Class 1 1Class 2a 38Class 2b 18Class 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 States43 registration records, 67 510(k), 0 PMA, 31 excluded

Brazil149 confirmed, 20 excluded

Saudi Arabia9 confirmed, 0 excluded

Canada51 confirmed, 4 excluded

Manufacturer names merged into this page: FUJIFILM CORPORATION · FUJIFILM Corporation

Business registration

Legal name: FUJIFILM Holdings Corporation
Corporate Number: 6010401065370
Registration status: Active
Registered capital: JPY 40,363,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

72018

202019

62020

52021

62022

22023

32024

82025

102026

FDA listed device types

showing 8 of 19

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Camera, Multi Format, Radiological 1System, X-Ray, Tomographic 1Full Field Digital, System, X-Ray, Mammographic 1Accelerator, Linear, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261170	BA-004CC	2026-08-12
US	K260567	EW10-EC02 Endoscopy Support Program	2026-08-07
US	K261880	FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01	2026-07-02
BR	10317490171	VIDEOENDOSCÓPIO SÉRIE 600 ZW	Class II
BR	10317490172	VIDEOENDOSCÓPIO SÉRIE 590	Class II
BR	10317490123	FIBROSCOPIO	Class II
SA	ME0000003983SFDAA00001	Forceps Valve	—
SA	ME0000015139SFDAA00013	Tube Kit	—
CA	2185	FUJI IMAGE READER FCR 5000	Class II
CA	7260	FUJI QA-WS771 QUALITY ASSURANCE WORK STATION	Class II
CA	11155	FUJI COMPACT IMAGE READER FCR AC-3	Class II

FUJIFILM CORPORATION

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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