FDA Device Entity Profile: Luxottica of America

Known Identifiers & Locations

FEI Numbers 3001654059, 3004576402, 3009586234, 3012297893

Owner Operator Numbers 9032320

Locations Covered AGORDO Belluno, IT; Chiba Tokyo, JP; Sedico Belluno, IT; St. Albans, Herts Hertfordshire, GB

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3004576402	Mirari Japan Co. Ltd.	Chiba Tokyo, JP	Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device,Manufacture Medical Device	View Details
3012297893	Luxottica North Europe Ltd.	St. Albans, Herts Hertfordshire, GB	Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device	View Details
9614827	LUXOTTICA Group SPA	AGORDO Belluno, IT	Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device	View Details
9614900	Luxottica Group S.P.A.	Sedico Belluno, IT	Export Device to the United States But Perform No Other Operation on Device,Foreign Private Label Distributor,Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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