HomeJapanSHIRAKAWA OLYMPUS CO., LTD.

SHIRAKAWA OLYMPUS CO., LTD.

Japan · Nishishirakawa-Gun Fukushima
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, 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
42listed device types
Class I 4Class II 37Class III 0unclassified 1
plus 104 registration records and 1 510(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
66valid device licences
Class I 1Class II 65
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States104 registration records, 1 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: SHIRAKAWA OLYMPUS CO., LTD.
Same-named companies — This database also contains companies with near-identical names: Olympus Shirakawa Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Nishishirakawa-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 510(k) clearances by year

12005 · K042274

FDA listed device types

showing 8 of 42
Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Access Overtube, Gastroenterology-Urology 1Device, Hardcopy, Images, Ophthalmic 1Laparoscope, Gynecologic (And Accessories) 1Endoscopic Leak Tester 1Laparoscope, General & Plastic Surgery 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1

Registration details (sample)

MarketIdentifierNameClass / date
USK042274PSD-60/ENDOPLASMA2005-02-22

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