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TOMEY CORPORATION

Japan · Nagoya-Shi

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 3Class II 3Class III 0

plus 6 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 2Class II 7

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

6active device licences

Class II 6

16 including historic records

TWTaiwanTFDA

11valid device licences

Class I 5Class II 6

SGSingaporeHSA SMDR

14device registrations

CLASS B 14

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 6

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

12active registrations

Class 2a 12

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 States6 registration records, 6 510(k), 0 PMA, 2 excluded

Brazil9 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: TOMEY CORPORATION

FDA 510(k) clearances by year

12002 · K012803

12008 · K073087

12018 · K171313

12022 · K213265

22025 · K252348

FDA listed device types

Topographer, Corneal, Ac-Powered 1Refractometer, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1Microscope, Specular 1Tomography, Optical Coherence 1Tonometer, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252348	Tomey Optical Biometer OA-2000 (OA-2000)	2025-12-18
US	K250553	Tomey Cornea/Anterior Segment OCT (CASIA2)	2025-07-18
US	K213265	Tomey Cornea/Anterior Segment OCT CASIA2	2022-04-27
BR	80102511800	PAQUÍMETRO E SCANNER ULTRASSÔNICO A/B	Class II
BR	80102511448	AUTO REFRA-CERATÔMETRO	Class II
BR	80102519060	MEDIDOR BIO & PACHY	Class II
CA	74218	AUTO REFRACTOMETER TR-4000	Class II
CA	74675	AUTO REF-TOPOGRAPHER RT-7000	Class II
CA	80270	TMS-4 TOPOGRAPHIC MODELING SYSTEM	Class II