Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040387972

FEI Number

3040387972

Entity Name

YINGTAN ZHONGHENG OPTICAL CO., LTD.

City/State/Country

Yingtan Jiangxi, CN

Establishment Address

Glasses Industrial Park, Yujiang District, Yingtan City, Jiangxi Province, Yingtan Jiangxi 335000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yingtan Zhongheng Optical Co., Ltd. (Owner Number: 10093928)

Owner / Operator Contact Address

Glasses Industrial Park, Yujiang District, Yingtan City, Jiangxi Province, Yingtan, CN-JX 335000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) Sunglasses (non-prescription including photosensitive) Frame, spectacle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-08-08
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-08-08
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-08-08

Official Correspondent

Wan Orwell

US Agent Details

Lisa Wright Lisa Wright Business: THE VISION COUNCIL Email: fda@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

Yingtan Zhongheng 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

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3021343301	TAIZHOU YIZHAN OPTICAL GLASSES CO., LTD	Taizhou City Zhejiang, CN
3015005459	TAIZHOU BAILIAN GLASSES MANUFACTURING CO, LTD	Taizhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040387972. Last updated year: 2026. Please use registration number 3040387972 when referencing this establishment in official correspondence.