Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021292813

FEI Number

3021292813

Entity Name

WENZHOU XINHEDA TRADE CO., LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

4th Floor, 123 Juguang Yuan Zhong Road, Nanjiao Street, Lucheng District,, Wenzhou Zhejiang 325000, CN

Establishment Type(s)

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

Owner / Operator

WENZHOU XINHEDA TRADE CO., LTD (Owner Number: 10083412)

Owner / Operator Contact Address

4th Floor, 123 Juguang Yuan Zhong Road, Nanjiao Street, Lucheng District,, Wenzhou, CN-ZJ 325029, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lens Frame Shield Spectacle

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	2021-11-17
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2021-11-17
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2021-11-17
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2021-11-17

Official Correspondent

XIEZHANG ZHU

US Agent Details

FANNY ZHAO Business: J & F TECHNOLOGY SERVICES Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

WENZHOU XINHEDA TRADE 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

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 3021292813. Last updated year: 2026. Please use registration number 3021292813 when referencing this establishment in official correspondence.