Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009262638

FEI Number

3009262638

Entity Name

WENZHOU EYECARE CO.,LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

508, Building 4, East Maanchi Road, Lucheng District, Wenzhou Zhejiang 325028, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wenzhou Eyecare Co.,Ltd (Owner Number: 10060637)

Owner / Operator Contact Address

508, Building 4, East Maanchi Road, Lucheng District, Wenzhou, CN-ZJ 325028, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Reading Glasses Optical Frames Sunglasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2019-06-05
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2019-06-05
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2019-06-05

Official Correspondent

Jane Lin

US Agent Details

Alex Gary Business: BTS US Inc Email: us@hibts.com Phone: (844) 9823583

Related Public Records

Same Entity

Wenzhou Eyecare 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
3013956081	RENEE'S READERS	New City, NY, US
3026270768	ASIASTAR INDUSTRY(HUIZHOU)CO., LTD	Huizhou City Guangdong, CN
3000180670	Dongguan Rijinyuehui Optical Co.,Ltd	Dongguan Guangdong, CN
3009206998	WORLDWIDE PACKAGING, INC	Livermore, CA, US
3013009176	HYUNDAI SAFETYWEAR CO.	Tainan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009262638. Last updated year: 2026. Please use registration number 3009262638 when referencing this establishment in official correspondence.