Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017965799

FEI Number

3017965799

Entity Name

ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD

City/State/Country

DANYANG Jiangsu, CN

Establishment Address

SOUTH OF SOUTH THIRD RING ROAD MAICUN VILLAGE, YUNYANG STREET, DANYANG Jiangsu 212300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD (Owner Number: 10079968)

Owner / Operator Contact Address

SOUTH OF SOUTH THIRD RING ROAD MAICUN VILLAGE, YUNYANG STREET, DANYANG, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

eyeglass eyewear UV blockers glasses magnifying resin lenses Eyeglass Frame magnifying Stock Lens Prescription spectacle lenses for the alleviation of reading discomfort UV blockers glasses Prescription Spectacle Lenses Eyeglass Frame Ophthalmic lenses magnifying UV blockers glasses spectacle Lens magnifying Frame Sunglasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2021-01-05
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2021-01-05
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2021-01-05
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2021-01-05

Official Correspondent

Serena Shi

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

ZHENJIANG NEW SHUOYAN OPTICS 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
3007009595	RAEN OPTICS	Oceanside, CA, US
3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017965799. Last updated year: 2026. Please use registration number 3017965799 when referencing this establishment in official correspondence.