Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005186804

FEI Number

3005186804

Entity Name

MONDOTTICA LTD

City/State/Country

Nottingham Nottinghamshire, GB

Establishment Address

Michael House, Riverside Business Park, Rennie Hogg Road, Nottingham Nottinghamshire NG2 1RX, GB

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Mondottica Ltd (Owner Number: 10026411)

Owner / Operator Contact Address

Michael House, Riverside Business Park, Rennie Hogg Road, Nottingham, GB-NTT NG2 1RX, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ted Baker Sandro Pepe Jeans Cath Kidston Christian Lacroix Karen Millen Hackett Yohji Yamamoto Joules Anna Sui Scotch and Soda Benetton Maje All Saints Florence by Mills Taylor Morris London Off-White Palm Angels Reebok Sunday Somewhere Sandro Ted Baker Maje Christian Lacroix Karen Millen Hackett Joules Pepe Jeans Cath Kidston Yohji Yamamoto Benetton Scotch and Soda All Saints Vivienne Westwood Reebok Taylor Morris London Palm Angels Florence by Mills Off-White Sunday Somewhere

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2008-07-11
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2008-07-11

Official Correspondent

Janice Carlin

US Agent Details

Regina Lage Business: Mondottica USA Email: rlage@mondotticausa.com Phone: (866) 6663662

Related Public Records

Same Entity

Mondottica Ltd

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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
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

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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005186804. Last updated year: 2026. Please use registration number 3005186804 when referencing this establishment in official correspondence.