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Home›Japan›FUJI SYSTEMS CORPORATION, Shirakawa Plant

FUJI SYSTEMS CORPORATION, Shirakawa Plant

Japan · Nishi Shirakawa Gun Fukushima
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, South Korea, Israel — 4 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 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
6valid device licences
Class I 1Class II 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States14 registration records, 0 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: FUJI SYSTEMS CORPORATION, Shirakawa Plant · FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant
Same-named companies — This database also contains companies with near-identical names: FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Nishi Shirakawa Gun Fukushima

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

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

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