Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005236311

FEI Number

3005236311

Entity Name

WENZHOU SANSHAN OPTICS CO., LTD.

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

No.108 Wenfeng Road, Puzhou Street, Longwan, WENZHOU Zhejiang 325011, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WENZHOU SANSHAN OPTICS CO., LTD. (Owner Number: 9074908)

Owner / Operator Contact Address

No. 108 Wefeng Road, Puzhou Street, Longwan, Wenzhou, CN-ZJ 325011, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SANSHAN Face Mask Face Mask SANSHAN SPS-01, SPS-02, SPS-03

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2005-07-06
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-25
NZJ	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies	General Hospital	Class 2	880.6260	2020-04-25
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2005-07-06
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-23

Official Correspondent

Kathy Zheng

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

WENZHOU SANSHAN OPTICS 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

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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 3005236311. Last updated year: 2026. Please use registration number 3005236311 when referencing this establishment in official correspondence.