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Topcon Healthcare Solutions, Inc.

USA · Oakland

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Singapore, Israel — 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

16listed device types

Class I 10Class II 6Class III 0

plus 22 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States22 registration records, 4 510(k), 0 PMA, 9 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: Topcon Healthcare, Inc. · Topcon Healthcare Solutions EMEA Oy

FDA 510(k) clearances by year

12020 · K200954

12021 · K210396

12023 · K232555

12026 · K253893

FDA listed device types

showing 8 of 16

Medical Device Data System 1Stand, Instrument, Ac-Powered, Ophthalmic 1Chart, Visual Acuity 1Chair, Ophthalmic, Manual 1Refractor, Manual, Non-Powered, Including Phoropter 1Projector, Ophthalmic 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Refractometer, Ophthalmic 1

Market	Identifier	Name	Class / date
US	K253893	Harmony Referral System with Harmony OCT Viewer (Octave)	2026-06-04
US	K232555	Harmony	2023-11-20
US	K210396	Harmony Referral System	2021-09-13

Topcon Healthcare Solutions, Inc.

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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