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Luneau Sas

France · Prunay-Le-Gillon

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 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

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

10 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 2Class 2a 2

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 States0 registration records, 5 510(k), 0 PMA, 6 excluded

Brazil1 confirmed, 2 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: LUNEAU SAS

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162067	VX130 Ophthalmic Diagnostic Device	2017-04-24
US	K143086	VX120 Ophthalmic Diagnostic Device	2015-06-01
US	K023838	LUNEAU STERILE TONOMETER SEPARATION PRISMS	2003-02-20
BR	80420200076	Dispositivo de Diagnóstico Oftalmológico	Class II
CA	6138	CURETTE STERILE	Class II
CA	9114	LAMINARIA DIGITATA	Class II
CA	61415	VERRE A 3 MIROIRS (3 MIRROR LENS)	Class II

Luneau Sas

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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