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Luxottica Group S.P.A.

Italy · Milan Milano

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Australia, Israel, Russia — 5 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

6listed device types

Class I 4Class II 2Class III 0

plus 8 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

6registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States8 registration records, 1 510(k), 0 PMA, 8 excluded

Saudi Arabia6 confirmed, 0 excluded

Manufacturer names merged into this page: LUXOTTICA GROUP S.P.A · Luxottica Group S.P.A. · Luxottica Group S.p.A.

FDA 510(k) clearances by year

12025 · K243150

FDA listed device types

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Air-Conduction Hearing Aid Software 1Lens, Spectacle, Non-Custom (Prescription) 1Spectacle, Magnifying 1Sunglasses (Non-Prescription Including Photosensitive) 1Frame, Spectacle 1

Market	Identifier	Name	Class / date
US	K243150	Nuance Audio Hearing Aid Software	2025-01-31
SA	ML0000000381SFDAA00002	CHANEL	—
SA	ME0000000333SFDAA00001	RX / Prescription Glasses	—

Luxottica Group S.P.A.

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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