Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012395063

FEI Number

3012395063

Entity Name

WENZHOU SMART VISION IMPORT & EXPORT CO., LTD

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

Building #5, No. 698 Zhonghui Road, LOUQIAO INDUSTRIAL ZONE, OUHAI, WENZHOU Zhejiang 325006, CN

Establishment Type(s)

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

Owner / Operator

WENZHOU SMART VISION IMPORT & EXPORT CO., LTD (Owner Number: 10055768)

Owner / Operator Contact Address

Building #5, No. 698 Zhonghui Road, LOUQIAO INDUSTRIAL ZONE, OUHAI, WENZHOU, CN-ZJ 325006, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sunglass Reading Glass ACCESSORY, SURGICAL APPAREL Prescription Lens goggles Shield, eye Face Shield Shield, protective, personnel

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	2017-10-05
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2017-10-05
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-14
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2022-05-28
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-14
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-04-14

Official Correspondent

ZHENG LIPING

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

WENZHOU SMART VISION IMPORT & EXPORT 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

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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 3012395063. Last updated year: 2026. Please use registration number 3012395063 when referencing this establishment in official correspondence.