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Home›Japan›KOWA CO. LTD. CHOFU

KOWA CO. LTD. CHOFU

Japan · Chofu T?Ky?
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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
6listed device types
Class I 1Class II 5Class III 0
plus 13 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 2Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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 States13 registration records, 1 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: KOWA CO. LTD. CHOFU · KOWA COMPANY, LTD. (CHOFU FACTORY) · Kowa Company, Ltd. Chofu Factory.
Same-named companies — This database also contains companies with near-identical names: KOWA COMPANY, LTD. (CHOFU FACTORY). Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Chofu T?Ky?

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

12019 · K190056

FDA listed device types

Camera, Ophthalmic, Ac-Powered 1System, Image Management, Ophthalmic 1Ophthalmoscope, Laser, Scanning 1Biomicroscope, Slit-Lamp, Ac-Powered 1Tonometer, Manual 1Perimeter, Automatic, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK190056KOWA VK-2s2019-02-12
BR10364090018Tonômetro de AplanaçãoClass II
BR10364099019Perimetro AutomáticoClass I
BR10364090020LÂMPADA DE FENDA PORTÁTILClass I
SAME0000004725SFDAA00001KOWA SL-17—
SAME0000004725SFDAA00003KOWA AP-7000—

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