Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004116534

FEI Number

3004116534

Entity Name

WENZHOU DONGYI OPTICAL CO.,LTD.

City/State/Country

WENZHOU, ZHEJIANG, CN

Establishment Address

No 85 Fengjiang Rd Economic &, Technological Development Zone, WENZHOU, ZHEJIANG --, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WENZHOU DONGYI OPTICAL CO.,LTD. (Owner Number: 9057891)

Owner / Operator Contact Address

NO 31 SMALL AREA ECONOMIC &, TECHNOLOGICAL ZONE, WENZHOU, ZHEJIANG, CN-NOTA --, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

7976ASBF SC-420 SC-293

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2003-08-06
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2003-08-06
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2003-08-06

Official Correspondent

No official correspondent registered.

US Agent Details

Peter Park Email: pjh25170108@gmail.com Phone: (626) 7152517

Related Public Records

Same Entity

WENZHOU DONGYI 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
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
3006755718	DONGGUAN YUEHENG OPTICAL CO. LTD.	Dongguan Guangdong, CN
3015534032	BOLLE SAFETY INC	Carlsbad, CA, US
3007675955	Carl Zeiss Vision Canada, Inc.	Toronto Ontario, CA
1000428458	GKB OPHTHALMICS LIMITED - UNIT II	North Goa Goa, IN
3038136215	MEIVISION (VIETNAM) CO., LTD	Ho Chi Minh City, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004116534. Last updated year: 2026. Please use registration number 3004116534 when referencing this establishment in official correspondence.