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KOWA COMPANY, LTD. (CHOFU FACTORY)

Japan

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, South Korea, Hong Kong, Israel — 7 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

8valid device licences

Class I 1Class II 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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.

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)

Market	Identifier	Name	Class / date
US	K190056	KOWA VK-2s	2019-02-12
BR	10364090018	Tonômetro de Aplanação	Class II
BR	10364099019	Perimetro Automático	Class I
BR	10364090020	LÂMPADA DE FENDA PORTÁTIL	Class I
SA	ME0000004725SFDAA00001	KOWA SL-17	—
SA	ME0000004725SFDAA00003	KOWA AP-7000	—

KOWA COMPANY, LTD. (CHOFU FACTORY)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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