Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009536223

FEI Number

3009536223

Entity Name

DUKE OPTICS (SHANGHAI) CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

Room 1403 Bldg A, 46 Ronghua East Road, Changning District, Shanghai 201103, CN

Establishment Type(s)

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

Owner / Operator

DUKE OPTICS (SHANGHAI) CO., LTD (Owner Number: 10043001)

Owner / Operator Contact Address

Room 1403 Bldg A, 46 Ronghua East Road, Changning District, Shanghai, CN-SH 201103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Optic Lens Lens Lens, spectacle Sunglasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2013-01-17
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2013-01-17

Official Correspondent

Fanny Zhao

US Agent Details

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

Related Public Records

Same Entity

DUKE OPTICS (SHANGHAI) 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
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
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

Registration Number	Establishment Name	Location
3012433574	Essilor Tijuana Optica	Tijuana Baja California, MX
8043274	JIANN LIH OPTICAL CO., LTD.	TAINAN City, TW
3038269608	Essilor Laboratories of America, Inc. dba Omega Northcreek Lab	Dallas, TX, US
3012981754	WEIFANG GOERTEK ELECTRONICS CO., LTD.	WEIFANG Shandong, CN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009536223. Last updated year: 2026. Please use registration number 3009536223 when referencing this establishment in official correspondence.