Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012251776

FEI Number

3012251776

Entity Name

WENZHOU KANGCHENG EYEWEAR CO., LTD.

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

1-5F,BUILDING 1, NO.2,ZHENNAN RD., WUTIAN INDUSTRIAL ZONE, OUHAI,WENZHOU, WENZHOU Zhejiang 325000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

WENZHOU KANGCHENG EYEWEAR CO., LTD. (Owner Number: 10050522)

Owner / Operator Contact Address

1-5F,BUILDING 1, NO.2,ZHENNAN RD., WUTIAN INDUSTRIAL ZONE, OUHAI,WENZHOU, 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

GLASS MEDICAL DROPPERS READERS READING GLASSES MAGNIFYING GLASSES Eyepatch SPECTACLE OPTICAL FRAME FRAME SUNGLASSES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2018-05-08
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2015-11-28
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2018-07-12
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2015-11-28
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2015-11-28

Official Correspondent

yongzhong HUANG

US Agent Details

James Liao Email: usa@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

WENZHOU KANGCHENG EYEWEAR 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

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3017528033	RYAN & ROSE, LLC	Bartlett, TN, US
3015216244	NANODROPPER, INC	Dover, DE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012251776. Last updated year: 2026. Please use registration number 3012251776 when referencing this establishment in official correspondence.