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Fujifilm Healthcare Corporation

Japan · Kashiwa-Shi

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Hong Kong, Israel, Russia — 7 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

62listed device types

Class I 14Class II 47Class III 1

plus 174 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

42active device licences

Class II 23Class III 19

89 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

19device registrations

CLASS B 19

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 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 States174 registration records, 19 510(k), 0 PMA, 25 excluded

Brazil4 confirmed, 19 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada42 confirmed, 3 excluded

Manufacturer names merged into this page: FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office · FUJIFILM Healthcare Manufacturing Corporation Sano Office · FUJIFILM Healthcare Americas Corporation · FUJIFILM Healthcare Manufacturing Corporation MIE Office · FUJIFILM HEALTHCARE AMERICAS CORPORATION · FUJIFILM HEALTHCARE CORPORATION

FDA 510(k) clearances by year

22022

72023

72024 · K241429

22025 · K251204

12026 · K261713

FDA listed device types

showing 8 of 62

Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Endoscopic Access Overtube, Gastroenterology-Urology 1Calibrator, Secondary 1Whole Slide Imaging System 1Calibrator, Primary 1Accelerator, Linear, Medical 1System, X-Ray, Tomography, Computed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261713	Synapse PACS (7.6.0)	2026-06-18
US	K251204	FUJIFILM Stiffening Wire Device (SW-2000)	2025-09-26
US	K243647	Synapse PACS (7.5)	2025-06-30
BR	80022060028	SYNAPSE (PACS)	Class II
BR	80005260011	SISTEMA DE IMAGEM POR RESSONÂNCIA MAGNÉTICA	Class II
BR	80005269006	SISTEMA DE ULTRASSOM DIAGNÓSTICO ARIETTA 65	Class II
CA	34758	CHOLESTEROL C2	Class II
CA	35046	TRIGLYCERIDES 20R/30R	Class II
CA	39223	L-TYPE LIPASE AND LIPASE CALIBRATOR	Class II

Fujifilm Healthcare 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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