HomeUSAAomori Olympus Co., Ltd.

Aomori Olympus Co., Ltd.

USA · Melville
✓ 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
36listed device types
Class I 6Class II 29Class III 0unclassified 1
plus 191 registration records and 7 510(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
87valid device licences
Class I 1Class II 86
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
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 States191 registration records, 7 510(k), 0 PMA
Manufacturer names merged into this page: Aomori Olympus Co., Ltd. Hirosaki Site · AOMORI OLYMPUS CO., LTD. Kuroishi Site

Company information

Country
USA
City
Melville

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

52003 · K033333
12004 · K041566
12005 · K042160

FDA listed device types

showing 8 of 36
Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Brush, Biopsy, Bronchoscope (Non-Rigid) 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1Lithotriptor, Biliary Mechanical 1Bronchoscope Accessory 1Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula 1

Registration details (sample)

MarketIdentifierNameClass / date
USK042160SONOSURG TROCAR2005-01-25
USK041566SONOSURG ULTRASONIC SURGICAL SYSTEM2004-09-08
USK033333SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B2003-11-14

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