HomeJapanKANEKA Corporation

KANEKA Corporation

Japan · Osaka-City
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 8 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
11510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
18device registrations
CLASS B 4CLASS C 1CLASS D 13
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class III 6IIa 1
HKHong KongMDACS
17valid listings
Class II 1Class IV 16
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 3 1
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 States0 registration records, 11 510(k), 0 PMA, 8 excluded
Manufacturer names merged into this page: KANEKA CORPORATION

Company information

Country
Japan
City
Osaka-City

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.

Business registration

Corporate Number
8120001059628
Registration status
Active
Registered capital
JPY 33,046,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12011
22015
42016 · K160013
32017 · K170941
12018 · K172264

Registration details (sample)

MarketIdentifierNameClass / date
USK172264OTW Takeru PTCA Balloon Dilatation Catheter2018-03-19
USK170941RX NC Takeru PTCA Balloon Dilatation Catheter2017-07-07
USK163372RX Takeru Balloon Dilatation Catheter2017-04-07

Similar companies

A2MediteX Corporation
Japan · markets 0
ACTIF CORPORATION CO., LTD
Japan · markets 0
Actment Co., Ltd
Japan · markets 0
Advanced Photonics, Inc.
Japan · markets 1
Advantec Toyo Kaisha, Ltd.
Japan · markets 0
ALCARE Co.,Ltd
Japan · markets 4
Is this your company? Claim the page, add information or report a data error.Claim / report an error →