Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043126854

FEI Number

3043126854

Entity Name

WENZHOU FULFILL IMPORT & EXPORT CO., LTD.

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

ROOM 1504, BUILDING B, E-COMMERCE BUILDING, NINGBO ROAD, PANQIAO STREET, OUHAI DISTRICT, WENZHOU Zhejiang 325000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

WENZHOU FULFILL IMPORT & EXPORT CO., LTD. (Owner Number: 10094654)

Owner / Operator Contact Address

ROOM 1504, BUILDING B, E-COMMERCE BUILDING, NINGBO ROAD, PANQIAO STREET, OUHAI DISTRICT, 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

Accessory Shields, protective Lens (reading) Optical Frame Lens (sunglasses) Sunglasses Eyeshields

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-12-14
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2025-12-14
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2025-12-14
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-12-14
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2025-12-14
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-12-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-12-14

Official Correspondent

Jeremy Zhang

US Agent Details

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

Related Public Records

Same Entity

WENZHOU FULFILL IMPORT & EXPORT 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
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043126854. Last updated year: 2026. Please use registration number 3043126854 when referencing this establishment in official correspondence.