HomeFranceESSILOR INTERNATIONAL - DIVISION INSTRUMENTS

ESSILOR INTERNATIONAL - DIVISION INSTRUMENTS

France · Charenton-Le-Pont
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia — 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
5listed device types
Class I 5Class II 0Class III 0
plus 9 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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 5IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States9 registration records, 0 510(k), 0 PMA, 17 excluded
Brazil11 confirmed, 0 excluded
Saudi Arabia55 confirmed, 1 excluded
Manufacturer names merged into this page: ESSILOR INTERNATIONAL, S.A. · ESSILOR INTERNATIONAL · ESSILOR INTERNATIONAL - DIVISION INSTRUMENTS · ESSILOR INTERNATIONAL SAS · Essilor International

Company information

Country
France
City
Charenton-Le-Pont

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Spectacle, Magnifying 1Digital Visual Acuity Test 1Lens, Spectacle (Prescription), For Reading Discomfort 1Lens, Spectacle, Non-Custom (Prescription) 1Frame, Spectacle 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80107040011Equipamento para diagnóstico refrativoClass I
BR80107049007Tonômetro AutomáticoClass II
BR80107049006Equipamento de medição de potência refrativaClass II
SAME0000011066SFDAA00001ORMA THIN TR VII GREY CRIZAL SAPPHIRE UV AIRMARK
SAME0000011066SFDAA00001ORMA THIN CRIZAL SAPPHIRE UV AIRMARK

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