Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007699038

FEI Number

3007699038

Entity Name

Jiangxi Alain Optical Ltd

City/State/Country

Yujiang Country,YingTan City Jiangxi, CN

Establishment Address

Glasses Industrial Park, Yujiang Country,YingTan City Jiangxi 335200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangxi Alain Optical LTD (Owner Number: 10029495)

Owner / Operator Contact Address

Glasses Industrial Park, Yujiang County, Yingtan City, CN-JX 335201, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2009-05-21
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2009-05-21
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2009-05-21

Official Correspondent

Yahong Sun

US Agent Details

Yahong Sun Business: Outspoken USA Inc Email: USA@outspokenholland.com Phone: (800) 5617708

Related Public Records

Same Entity

Jiangxi Alain Optical 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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007699038. Last updated year: 2026. Please use registration number 3007699038 when referencing this establishment in official correspondence.