Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004378828

FEI Number

3004378828

Entity Name

DONGGUAN CONCEPT EYEWEAR MANUFACTURER LTD.

City/State/Country

FENG GANG, Guangdong, CN

Establishment Address

No.33 HONG SHI ROAD, YANTIAN VILLAGE,, FENGGANG TOWN, DONGGUAN, FENG GANG, Guangdong 523702, CN

Establishment Type(s)

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

Owner / Operator

CONCEPT EYEWEAR MANUFACTURER LTD. (Owner Number: 9052880)

Owner / Operator Contact Address

Unit 9, 7/F, Westley Square,, 48 Hoi Yuen Road,, KWUN TONG, KOWLOON, HK-NOTA --, HK

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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2003-12-19
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2003-12-19
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2007-08-03

Official Correspondent

Thomas Pang

US Agent Details

Thomas Pang Business: kapo optik Email: kapo_optik@yahoo.com Phone: (626) 2266699

Related Public Records

Same Entity

CONCEPT EYEWEAR MANUFACTURER LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003782728	CONCEPT EYEWEAR MANUFACTURER LTD.	KWUN TONG, KOWLOON, HK

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
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004378828. Last updated year: 2026. Please use registration number 3004378828 when referencing this establishment in official correspondence.