Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019021940

FEI Number

3019021940

Entity Name

UNIVERSE OPTICAL MFG CO.,LTD

City/State/Country

zhenjiang Jiangsu, CN

Establishment Address

4F,Fanhua Mansion No.116 Dingmaoqiao Road,, zhenjiang Jiangsu 212003, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UNIVERSE OPTICAL MFG CO.,LTD (Owner Number: 10080863)

Owner / Operator Contact Address

4F,Fanhua Mansion No.116 Dingmaoqiao Road,, zhenjiang, CN-JS 212003, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UO UO UO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2021-03-03
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2021-03-03
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2021-03-03

Official Correspondent

LEI GAO

US Agent Details

Ignacio Casco Business: GENERAL OPTICS LLC Email: ignacio@generaloptics.us Phone: (305) 6312575

Related Public Records

Same Entity

UNIVERSE OPTICAL MFG 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
3013956081	RENEE'S READERS	New City, NY, US
3026270768	ASIASTAR INDUSTRY(HUIZHOU)CO., LTD	Huizhou City Guangdong, CN
3000180670	Dongguan Rijinyuehui Optical Co.,Ltd	Dongguan Guangdong, CN
3009206998	WORLDWIDE PACKAGING, INC	Livermore, CA, US
3013009176	HYUNDAI SAFETYWEAR CO.	Tainan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019021940. Last updated year: 2026. Please use registration number 3019021940 when referencing this establishment in official correspondence.