Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009266621

FEI Number

3009266621

Entity Name

NiTec Eyewear (Dalian) Inc.

City/State/Country

Dalian Liaoning, CN

Establishment Address

Yangshufang Economic Development Zone, Pulandian, Dalian City, Liaoning Province, Dalian Liaoning 116215, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NiTec Eyewear (Dalian) Inc. (Owner Number: 10037685)

Owner / Operator Contact Address

Yangshufang Economic Development Zone,, Pulandian District, Dalian, CN-LN 116215, 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
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2011-10-28
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2011-08-08
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2011-10-28

Official Correspondent

Yang Li

US Agent Details

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

Related Public Records

Same Entity

NiTec Eyewear (Dalian) Inc.

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

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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 3009266621. Last updated year: 2026. Please use registration number 3009266621 when referencing this establishment in official correspondence.