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REXXAM.CO., LTD.

Japan · Takamatsu Kagawa

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Israel, 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

9listed device types

Class I 9Class II 0Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 3Class II 5

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 4IIa 1Class Im (measuring) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

10active registrations

Class 1 7Class 2a 3

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 States9 registration records, 0 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Manufacturer names merged into this page: REXXAM.CO., LTD. · REXXAM CO, LTD. · REXXAM CO.,LTD. · Rexxam Co, Ltd.

FDA listed device types

showing 8 of 9

Set, Lens, Trial, Ophthalmic 1Pupillometer, Manual 1Chart, Visual Acuity 1Refractor, Manual, Non-Powered, Including Phoropter 1Projector, Ophthalmic 1Frame, Trial, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1Refractometer, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10364090016	Refrator Digital	Class I
BR	10364099048	Auto Ref/Cerato/Tonômetro Rexxam	Class II
BR	10364090019	Lâmpada de Fenda	Class I
SA	ME0000008492SFDAA00006	LCD CHART	—
SA	ME0000008492SFDAA00002	LED SLIT LAMP	—

REXXAM.CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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