Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012981754

FEI Number

3012981754

Entity Name

WEIFANG GOERTEK ELECTRONICS CO., LTD.

City/State/Country

WEIFANG Shandong, CN

Establishment Address

Gaoxin 2 Road, Free Trade Zone, WEIFANG Shandong 261205, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Goertek Inc (Owner Number: 10052631)

Owner / Operator Contact Address

Gaoxin 2 Road, Free Trade Zone, WEIFANG, CN-SD 261205, 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
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2016-08-30
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2016-08-30
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2016-08-30

Official Correspondent

George Yang

US Agent Details

Richard Shea Email: richard.shea@goertekusa.com Phone: (425) 7866685

Related Public Records

Same Entity

Goertek Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017122860	GOERTEK TECHNOLOGY VINA CO.,LTD	Bac Ninh city, VN
3037611336	Goertek Smart Technology Vina Co.,Ltd.	Bac Ninh, VN
3039431671	Qingdao Goertek Horizons Technology Co., Ltd.	Qingdao Shandong, CN

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
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8043274	JIANN LIH OPTICAL CO., LTD.	TAINAN City, TW
3038269608	Essilor Laboratories of America, Inc. dba Omega Northcreek Lab	Dallas, TX, US
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
3012414867	Taizhou Jiahong Glasses Co.,Ltd	Taizhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012981754. Last updated year: 2026. Please use registration number 3012981754 when referencing this establishment in official correspondence.