Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011247894

FEI Number

3011247894

Entity Name

WENZHOU SUNTRACK OPTICAL CO., LTD.

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

4F Building 1, 8 Xindi Road,, Sanxi Economic Development Zone, Wenzhou Zhejiang 325000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Wenzhou Suntrack Optical Co., Ltd. (Owner Number: 10047614)

Owner / Operator Contact Address

4F Building 1, 8 Xindi Road,, Sanxi Economic Development Zone, 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

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2014-10-12
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2014-10-12

Official Correspondent

Zhengping Qin

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Wenzhou Suntrack Optical 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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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011247894. Last updated year: 2026. Please use registration number 3011247894 when referencing this establishment in official correspondence.