Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007120545

FEI Number

3007120545

Entity Name

KERVIEW S.A.

City/State/Country

MONTEVIDEO, UY

Establishment Address

Ituzaingo 1309 Office 101, MONTEVIDEO 11000, UY

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

Owner / Operator

KERVIEW S.A. (Owner Number: 10052756)

Owner / Operator Contact Address

ITUZAINGO 1309 OFFICE 101, MONTEVIDEO, UY-MO 11000, UY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2016-11-23
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2016-11-23

Official Correspondent

MARTIN CROM

US Agent Details

Lisa Wright Business: The Vision Council Email: fda@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

KERVIEW S.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

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 3007120545. Last updated year: 2026. Please use registration number 3007120545 when referencing this establishment in official correspondence.