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NIDEK INCORPORATED

USA · Gamagori

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Russia — 9 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

25listed device types

Class I 11Class II 13Class III 1

plus 64 registration records and 98 510(k), 29 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

13registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

31active device licences

Class II 20Class III 11

77 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

40device registrations

CLASS B 29CLASS C 11

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

27active ARTG entries

Class I 8IIa 14IIb 3Class Im (measuring) 2

HKHong KongMDACS

26valid listings

Class II 21Class III 5

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

6active registrations

Class 2a 4Class 2b 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 States64 registration records, 98 510(k), 29 PMA, 4 excluded

Brazil3 confirmed, 2 excluded

Saudi Arabia13 confirmed, 0 excluded

Canada31 confirmed, 2 excluded

Manufacturer names merged into this page: NIDEK INCORPORATED · NIDEK CO., LTD. · NIDEK CO., LTD · NIDEK CO., LTDA · NIDEK Co, Ltd. · Nidek Co. Ltd.

FDA 510(k) clearances by year

11996

41997

71998

21999

12000

12001

52002

22003

12004

12005

12008

22011

32013

32014

32016

22017

22018

22019

12020

12023

FDA listed device types

showing 8 of 25

Tonometer, Ac-Powered 1Microscope, Specular 1Camera, Ophthalmic, Ac-Powered 1Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Laser, Ophthalmic 1Tomography, Optical Coherence 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221320	Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX	2023-03-30
US	K203130	Ophthalmic Yag Laser System YC-200	2020-12-07
US	K192045	Ophthalmic Yag Laser System YC-200	2019-11-15
BR	80625080017	SOFTWARE DE ARQUIVAMENTO DE IMAGEM	Class II
BR	80625080052	PROJETOR DE TABELAS	Class I
BR	80625080005	NEX-IJ	Class II
SA	ME0000004982SFDAA00001	System Table	—
SA	ME0000004982SFDAA00002	Refractor	—
CA	30293	AUTO REFRACTOMETER	Class II
CA	30329	AUTO REF / KERATOMETER	Class II
CA	70794	EC-5000 CX III EXCIMER LASER CORNEAL SURGERY SYSTEM	Class III

NIDEK INCORPORATED

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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