Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011674724

FEI Number

3011674724

Entity Name

WENZHOU SUTUS OPTICAL MANUFACTORY LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

2nd-3rd F, 2666 Ouhai Avenue, Guoxi Street, Ouhai, Wenzhou Zhejiang 325000, CN

Establishment Type(s)

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

Owner / Operator

Wenzhou Sutus Optical Manufactory Ltd (Owner Number: 10053858)

Owner / Operator Contact Address

2nd-3rd F, 2666 Ouhai Avenue, Guoxi Street, 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

Glass frame Reading Glass Sunglasses NYS FREYRS WMP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2017-01-17
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2017-01-17
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2017-01-17

Official Correspondent

Charles Shen

US Agent Details

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

Related Public Records

Same Entity

Wenzhou Sutus Optical Manufactory 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011674724. Last updated year: 2026. Please use registration number 3011674724 when referencing this establishment in official correspondence.