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ESSILOR INTERNATIONAL, S.A.

France · Ligny En Barrois Meuse

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Israel — 7 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

21listed device types

Class I 15Class II 6Class III 0

plus 29 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 5Class II 6

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

SASaudi ArabiaSFDA

55registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

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 States29 registration records, 0 510(k), 0 PMA, 16 excluded

Brazil11 confirmed, 0 excluded

Saudi Arabia55 confirmed, 1 excluded

Manufacturer names merged into this page: ESSILOR International Usine de la Compasserie · ESSILOR INTERNATIONAL, S.A. · ESSILOR INTERNATIONAL · ESSILOR INTERNATIONAL - DIVISION INSTRUMENTS · ESSILOR INTERNATIONAL SAS · Essilor International

FDA listed device types

showing 8 of 21

Tonometer, Ac-Powered 1Ophthalmoscope, Ac-Powered 1Device, Analysis, Anterior Segment 1Biomicroscope, Slit-Lamp, Ac-Powered 1Tonometer, Manual 1Retinoscope, Ac-Powered 1Medical Device Data System 1Spectacle, Magnifying 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80107040011	Equipamento para diagnóstico refrativo	Class I
BR	80107049007	Tonômetro Automático	Class II
BR	80107049006	Equipamento de medição de potência refrativa	Class II
SA	ME0000011066SFDAA00001	ORMA THIN TR VII GREY CRIZAL SAPPHIRE UV AIRMARK	—
SA	ME0000011066SFDAA00001	ORMA THIN CRIZAL SAPPHIRE UV AIRMARK	—

ESSILOR INTERNATIONAL, S.A.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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