HomeJapanKowa Company , Ltd.

Kowa Company , Ltd.

Japan · Chuo-Ku Tokyo
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, 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
19510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 19 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
6device registrations
CLASS B 3CLASS C 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1Class Im (measuring) 1
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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, 19 510(k), 0 PMA, 4 excluded
Brazil2 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: KOWA COMPANY, LTD.

Company information

Country
Japan
City
Chuo-Ku Tokyo

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

Legal name
KOWA COMPANY, LTD.
Corporate Number
1180001035811
Registration status
Active
Registered capital
JPY 3,840,000,000

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

32005
42006
22008
42009
12011
12012
12014
22019
12022

Registration details (sample)

MarketIdentifierNameClass / date
USK222372Kowa SL-192022-11-21
USK191945KOWA nonmyd 82019-09-10
USK190573KOWA DR-1a2019-06-04
BR10364099018Lâmpada de Fenda PortátilClass I
BR10364099017Câmara RetinográficaClass II

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