HomeJapanFUJIFILM Healthcare Manufacturing Corporation Sano Office

FUJIFILM Healthcare Manufacturing Corporation Sano Office

Japan · Sano City Tochigi
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, South Korea — 3 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
26listed device types
Class I 6Class II 20Class III 0
plus 63 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 States63 registration records, 0 510(k), 0 PMA, 5 excluded
Brazil2 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: FUJIFILM Healthcare Manufacturing Corporation Sano Office · FUJIFILM CORPORATION: FUJIFILM OPTICS CO., LTD, FUJINON SANO CORPORATION

Company information

Country
Japan
City
Sano City Tochigi

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 26
Endoscopic Access Overtube, Gastroenterology-Urology 1Laparoscope, General & Plastic Surgery 1Enteroscope And Accessories 1Forceps, Biopsy, Electric 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1System, Imaging, Pulsed Doppler, Ultrasonic 1Oximeter, Tissue Saturation 1Led Light Source 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10317490094ENDOSCÓPIO FLEXÍVELClass II
BR10317490115VÍDEOENDOSCÓPIO SÉRIE 200Class II

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