Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007801751

FEI Number

3007801751

Entity Name

JIANGSU HONGCHEN OPTICAL CO., LTD.

City/State/Country

DANYANG Jiangsu, CN

Establishment Address

NO.985 YINGCHUN ROAD, DEVELOPMENT ZONE, DANYANG Jiangsu 212300, CN

Establishment Type(s)

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

Owner / Operator

Jiangsu Hongchen Optical Co., Ltd. (Owner Number: 10089660)

Owner / Operator Contact Address

NO.985 YINGCHUN ROAD, DEVELOPMENT ZONE, 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

Optical Lenses, Spectacle lenses, Prescription Lenses, Blue Light Blocked Lenses, Polycarbonate Lenses Eyeglass Frame

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	2023-12-27
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2023-12-27

Official Correspondent

Yan Zhang

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Hongchen Optical 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007801751. Last updated year: 2026. Please use registration number 3007801751 when referencing this establishment in official correspondence.