Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009515444

FEI Number

3009515444

Entity Name

GINO OPTICAL (SHANGHAI) CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

No.800, Qingdai RD, Pudong, Shanghai 201318, CN

Establishment Type(s)

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

Owner / Operator

GINO OPTICAL (SHANGHAI) CO., LTD. (Owner Number: 10083895)

Owner / Operator Contact Address

No.800, Qingdai RD, Pudong, Shanghai, CN-SH 201318, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Projector, ophthalmic Lens PD METER Refractor, manual, non- powered, including phoropter Frame Table, instrument, powered, ophthalmic Tester, color vision LENS METER Instrument, measuring, lens, ac-powered Refractometer, ophthalmic Chart, visual acuity

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2022-03-10
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2021-12-28
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2022-03-10
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2022-03-10
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2021-12-28
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2022-03-10
HIT	Tester, Color Vision	Ophthalmic	Class 1	886.1170	2022-03-10
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2022-03-10
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2022-03-10
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2022-03-10

Official Correspondent

Jianfang Ye

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

GINO OPTICAL (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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

Similar Registrations

Registration Number	Establishment Name	Location
9614661	TOPCON CORP.	TOKYO, JP
3010363281	EVERVIEW CORP	Geumcheon-gu Seoul, KR
3033566	OCULUS, INC.	Arlington, WA, US
3015972897	INNOVA MEDICAL OPHTHALMICS	Toronto Ontario, CA
3004095901	LIANYUNGANG TIANNUO OPTICAL INSTRUMENT CO., LTD.	LIANYUNGANG Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009515444. Last updated year: 2026. Please use registration number 3009515444 when referencing this establishment in official correspondence.