Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003116697

FEI Number

3003116697

Entity Name

SAFILO S.P.A.

City/State/Country

PADOVA Veneto, IT

Establishment Address

SETTIMA STRADA N.15, PADOVA Veneto 35129, IT

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SAFILO S.P.A. (Owner Number: 9049745)

Owner / Operator Contact Address

SETTIMA STRADA N.15, --, PADOVA, IT-NOTA 35129, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAFILO DOO SAFILO SAFILO SPA SAFILO SAFILO SPA SAFILO SAFILO DOO SAFILO SPA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1998-01-29
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1998-03-03
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2017-02-24

Official Correspondent

Simone Carli

US Agent Details

Kimberly Herrera Business: SAFILO USA Email: kimberly.herrera@safilo.com Phone: (303) 5868747

Related Public Records

Same Entity

SAFILO S.P.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

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3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003116697. Last updated year: 2026. Please use registration number 3003116697 when referencing this establishment in official correspondence.