Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2243610

FEI Number

2243610

Entity Name

Marcolin U.S.A. Eyewear Corp.

City/State/Country

Somerville, NJ, US

Establishment Address

3140 RT. 22 WEST, Somerville, NJ 08876, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MARCOLIN USA (Owner Number: 9031641)

Owner / Operator Contact Address

3140 Route 22 West, Somerville, NJ 08876, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Harley-Davidson Rag & Bone Abercrombie Kids Harley-Davidson WEB EYEWEAR GUESS Timberland Viva Eyewear GCDS adidas Sport Bally Abercrombie & Fitch Co. Candie's Marcolin Eyewear Marciano Max Mara Tom Ford Eyewear Skechers MAX&Co. GANT adidas Originals Kenneth Cole New York SPORTMAX Zegna MCM K-Way Kenneth Cole Reaction Christan Louboutin Tods Eyewear Hollister BMW MONCLER Pucci Hollister Zegna adidas Originals Timberland GANT WEB EYEWEAR Marciano MCM Tods Eyewear Harley-Davidson Christian Louboutin GCDS MONCLER Kenneth Cole Reaction Candie's SPORTMAX BMW MAX & Co. Abercrombie Kids K-Way adidas Sport Tom Ford Eyewear Marcolin GUESS Max Mara Pucci Skechers Bally Abercrombie & Fitch Co. Kenneth Cole New York Viva Eyewear Rag & Bone

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2003-02-05
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2003-02-05
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2002-05-10

Official Correspondent

Celina Renda

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MARCOLIN USA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9710062	ic! berlin GmbH	BERLIN, DE
3002719961	MARCOLIN SPA	LONGARONE Belluno, IT

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

Similar Registrations

Registration Number	Establishment Name	Location
3013956081	RENEE'S READERS	New City, NY, US
3026270768	ASIASTAR INDUSTRY(HUIZHOU)CO., LTD	Huizhou City Guangdong, CN
3000180670	Dongguan Rijinyuehui Optical Co.,Ltd	Dongguan Guangdong, CN
3009206998	WORLDWIDE PACKAGING, INC	Livermore, CA, US
3013009176	HYUNDAI SAFETYWEAR CO.	Tainan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2243610. Last updated year: 2026. Please use registration number 2243610 when referencing this establishment in official correspondence.