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LUNEAU TECHNOLOGY OPERATIONS

France · Pont-De-L'Arche

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

12listed device types

Class I 7Class II 5Class III 0

plus 13 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

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

9 including historic records

TWTaiwanTFDA

10valid device licences

Class I 9Class II 1

SGSingaporeHSA SMDR

8device registrations

CLASS B 8

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

5registrations

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 States13 registration records, 1 510(k), 0 PMA, 6 excluded

Brazil5 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: LUNEAU TECHNOLOGY OPERATIONS

FDA 510(k) clearances by year

12021 · K202221

FDA listed device types

showing 8 of 12

Esthesiometer, Ocular 1Chart, Visual Acuity 1Refractor, Manual, Non-Powered, Including Phoropter 1Rack, Skiascopic 1Refractometer, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1Prism, Bar, Ophthalmic 1Tonometer, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202221	VX650	2021-01-29
BR	80107040012	Equipamento de Diagnóstico Oftalmológico	Class I
BR	10378479002	SCANNER DNEye 2	Class II
BR	80170800017	Dispositivo Multifuncional de Diagnóstico Ocular Visionix	Class I

LUNEAU TECHNOLOGY OPERATIONS

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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