Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011770145

FEI Number

3011770145

Entity Name

WENZHOU KANGYE IMP. & EXP. CO., LTD

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

19F-02, Yipin International, Sanyang Ouhai, 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 KANGYE IMP. & EXP. CO., LTD (Owner Number: 10054798)

Owner / Operator Contact Address

19F-02, Yipin International, Sanyang Ouhai, WENZHOU, CN-ZJ 325000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OPTICAL FRAME, SPECTACLE FRAME SUNGLASSES READING GLASSES, MAGNIFYING SPECTACLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2017-04-27
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2017-04-27
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2017-04-27

Official Correspondent

Susan Zhou

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

WENZHOU KANGYE IMP. & EXP. 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
3007521479	NY2LA INC.	Camarillo, CA, US
3005147601	VISIONTECH EXPORT INTERNATIONAL (PVT) LTD.	KARACHI Sindh, PK
3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011770145. Last updated year: 2026. Please use registration number 3011770145 when referencing this establishment in official correspondence.