Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013004948

FEI Number

3013004948

Entity Name

WENZHOU DUOLA TRADE CO., LTD.

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

5TH FLOOR , DOMITORY BUILDING ,B-7 PLOT STANDARD INDUSTRIAL FACTORY BUILDING , RUO LI AO , HUANGLONG, SHUANGYU STREET, LUCHENG DISTRICT, Wenzhou Zhejiang 325000, CN

Establishment Type(s)

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

Owner / Operator

WENZHOU DUOLA TRADE CO., Ltd. (Owner Number: 10052831)

Owner / Operator Contact Address

5TH FLOOR , DOMITORY BUILDING ,B-7 PLOT STANDARD INDUSTRIAL FACTORY BUILDING , RUO LI AO , HUANGLONG, SHUANGYU STREET, LUCHENG 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

OPTICAL FRAME SUNGLASSES OPTICAL FRAME READING GLASSES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2016-10-11
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2016-10-11
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2019-02-18
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2016-10-11

Official Correspondent

Li Sun

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

WENZHOU DUOLA TRADE 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
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
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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1219313	CARWILD CORP.	NEW LONDON, CT, US
3008812251	Swann-Morton(Services) Limited	Owlerton Green Sheffield, GB
2529846	MED SAVER, INC.	PHOENIXVILLE, PA, US
1319660	ISOMEDIX OPERATIONS INC.	CHESTER, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013004948. Last updated year: 2026. Please use registration number 3013004948 when referencing this establishment in official correspondence.