Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039431671

FEI Number

3039431671

Entity Name

Qingdao Goertek Horizons Technology Co., Ltd.

City/State/Country

Qingdao Shandong, CN

Establishment Address

Building 1 ,2, Qingdao Virtual Reality Industrial Park, No.159 Zhuzhou Road, Laoshan District, Qingdao Shandong 266101, 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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	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
3012981754	WEIFANG GOERTEK ELECTRONICS CO., LTD.	WEIFANG Shandong, CN

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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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039431671. Last updated year: 2026. Please use registration number 3039431671 when referencing this establishment in official correspondence.