Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043585860

FEI Number

3043585860

Entity Name

CARLO SESTINI SRL

City/State/Country

Milano, IT

Establishment Address

Via Aurelio Saffi 21, Milano 20123, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Foreign Private Label Distributor

Owner / Operator

Carlo Sestini Srl (Owner Number: 10095034)

Owner / Operator Contact Address

Via Aurelio Saffi 21, Milano, IT-MI 20123, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Carlo Sestini Carlo Sestini

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	2026-01-16
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2026-01-16

Official Correspondent

Enrico Novelli

US Agent Details

Caterina Zimmerman Business: Pangea Export USA LLC Email: info@pangeaexport.us Phone: (415) 2506061

Related Public Records

Same Entity

Carlo Sestini Srl

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

Similar Registrations

Registration Number	Establishment Name	Location
3007009595	RAEN OPTICS	Oceanside, CA, US
3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
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 3043585860. Last updated year: 2026. Please use registration number 3043585860 when referencing this establishment in official correspondence.