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Topcon Corporation

Japan · Tokyo

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

18listed device types

Class I 11Class II 7Class III 0

plus 43 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class I 5Class II 10

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

52 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

16device registrations

CLASS B 16

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

13active ARTG entries

Class I 4IIa 6Class Im (measuring) 3

HKHong KongMDACS

6valid listings

Class II 6

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

22active registrations

Class 1 2Class 2a 20

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 States43 registration records, 22 510(k), 0 PMA, 11 excluded

Brazil15 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: TOPCON CORP. · TOPCON CORPORATION · Topcon Corporation

Business registration

Corporate Number: 4011401004725
Registration status: Active
Registered capital: JPY 16,984,000,000

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

12004

12007

12008

22009

12010

12013

32014

12015

22016

22017

12018

12022

12023

32024

12025

FDA listed device types

showing 8 of 18

Set, Lens, Trial, Ophthalmic 1Instrument, Measuring, Corneal Radius 1Pupillometer, Manual 1Chart, Visual Acuity 1Refractor, Manual, Non-Powered, Including Phoropter 1Projector, Ophthalmic 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253039	AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA	2025-11-07
US	K241081	3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System	2024-07-17
US	K233561	3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))	2024-04-10
BR	80117589161	Sistema de refração	Class II
BR	80117589149	AUTO QUERATO/REFRATO TONÔMETRO	Class II
BR	80117580683	Vision Tester VT-10	Class II
SA	ME0000004660SFDAA00001	ADJUSTABLE INSTRUMENTS TABLE	—
CA	63841	AUTO REFRACTOMETER	Class II
CA	77731	AUTO REFRACTOMETER RM-8900	Class II
CA	77834	AUTO KERATO-REFRACTO-TONOMETER	Class II