HomeJapanAIZU OLYMPUS CO., LTD.

AIZU OLYMPUS CO., LTD.

Japan · Aizuwakamatsu-Shi 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
28listed device types
Class I 4Class II 24Class III 0
plus 77 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
73valid device licences
Class I 1Class II 72
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 States77 registration records, 1 510(k), 0 PMA
Manufacturer names merged into this page: AIZU OLYMPUS CO., LTD.

Company information

Country
Japan
City
Aizuwakamatsu-Shi 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 · K043487

FDA listed device types

showing 8 of 28
Cystoscope And Accessories, Flexible/Rigid 1Accessories, Cleaning, For Endoscope 1Laparoscope, Gynecologic (And Accessories) 1Laparoscope, General & Plastic Surgery 1Endoscope Channel Accessory 1Nasopharyngoscope (Flexible Or Rigid) 1Enteroscope And Accessories 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1

Registration details (sample)

MarketIdentifierNameClass / date
USK043487EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/12005-01-28

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