Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012851284

FEI Number

3012851284

Entity Name

Inditex S.A.

City/State/Country

Arteixo A Coruna, ES

Establishment Address

PG I. Sabon., Ave Diputacion, Arteixo A Coruna 15143, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Zara USA INC (Owner Number: 10032979)

Owner / Operator Contact Address

500 5th Avenue Suite 400, Manhattan, NY 10110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BERSHKA ZARA

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	2017-05-30

Official Correspondent

Maria Gilabert

US Agent Details

David Whittingham Business: United Customs Services, Inc. Email: ucsbroker@gmail.com Phone: (305) 6399584

Related Public Records

Same Entity

Zara USA INC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
206165	Bershka BSK Espana S.A.	Arteixo A Coruna, ES
3009944275	Grupo Massimo Dutti S.A.	ARTEIXO A Coruna, ES

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 3012851284. Last updated year: 2026. Please use registration number 3012851284 when referencing this establishment in official correspondence.