Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014167550

FEI Number

3014167550

Entity Name

GUANGDONG DEXIN SPORTS INDUSTRY CO.,LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Xinzhuang Section, Furong Road, Huadu District, Guangzhou Guangdong 510850, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGDONG DEXIN SPORTS INDUSTRY CO.,LTD (Owner Number: 10086739)

Owner / Operator Contact Address

Xinzhuang Section, Furong Road, Huadu District, Guangzhou, CN-GD 510850, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

forehead thermometer gun Bluetooth glasses Q-VT9,Q-VT10 ,Q-VT11,Q-VT12,Q-VT13,QVT14,Q-VT15,Q-VT16,Q-VT17,Q-VT18, DEX19,DEX20,DEX21,DEX22,DEX23 Sun glasses DEX24,DEX25,DEX26,DEX27,DEX28 Radiation glasses Myopic glasses; Presbyopic glasses Snorkel Masks Scavenging; Protective face shield SP06 Cover, shoe, operating- room KN95 mask CAP SURGICAL Full Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2022-12-07
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2022-12-07
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2022-12-19
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2022-12-19
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2023-03-02
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2022-12-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2022-12-07
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-12-19
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-12-07
QOZ	Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy	Unknown	Class N	N/A	2023-03-02

Official Correspondent

Tony Tang

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

GUANGDONG DEXIN SPORTS INDUSTRY CO.,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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Similar Registrations

Registration Number	Establishment Name	Location
3011983031	VERMONT MANUFACTURING SERVICES, INC.	West Rutland, VT, US
3001650535	Suzhou Meccan Import and Export Corp.	Suzhou Jiangsu, CN
3016450032	PLANET HOLDINGS LIMITED	Hong Kong, HK
3011066654	SHENZHEN JOOSE BEAUTY ELECTRONIC CO.,LTD	Shen Zhen Guangdong, CN
8043323	FOURSTAR GROUP INC.	TAIPEI, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014167550. Last updated year: 2026. Please use registration number 3014167550 when referencing this establishment in official correspondence.