Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037611336

FEI Number

3037611336

Entity Name

Goertek Smart Technology Vina Co.,Ltd.

City/State/Country

Bac Ninh, VN

Establishment Address

Lot A1, Nam Son - Hap Linh Industrial Park, Nam Son Ward, Hap Linh Ward and, Tan Chi Commune,, Bac Ninh 16121, VN

Establishment Type(s)

Manufacture Medical Device

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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2016-08-30
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	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
3039431671	Qingdao Goertek Horizons Technology Co., Ltd.	Qingdao Shandong, CN
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

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3038269608	Essilor Laboratories of America, Inc. dba Omega Northcreek Lab	Dallas, TX, US
3012981754	WEIFANG GOERTEK ELECTRONICS CO., LTD.	WEIFANG Shandong, CN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037611336. Last updated year: 2026. Please use registration number 3037611336 when referencing this establishment in official correspondence.