Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014161178

FEI Number

3014161178

Entity Name

GUANG ZHOU HE CHANG OPTICAL CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Floor 1-4, Building 3, No.4 Qiling Street, Shiling Town, Huadu District, Guangzhou Guangdong 510800, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guang Zhou He Chang Optical Co.,Ltd. (Owner Number: 10056716)

Owner / Operator Contact Address

Floor 1-4, Building 3, No.4 Qiling Street, Shiling Town, Huadu District, Guangzhou, CN-GD 510800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sunglasses Frames Goggle, Motocross Goggle, Safety Glasses, Protective Glasses, Tactical Glasses Face mask, Protective Visors

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	2018-01-09
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2018-01-09
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-06
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2024-02-11

Official Correspondent

Crystal Au

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Guang Zhou He Chang Optical Co.,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
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 3014161178. Last updated year: 2026. Please use registration number 3014161178 when referencing this establishment in official correspondence.