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Data / Medical devices / China / Guangdong Dexin Sports Industry Co.,ltd

Guangdong Dexin Sports Industry Co.,ltd: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance

Guangdong Dexin Sports Industry Co.,ltd is registered with the FDA (registration 3014167550) in Guangzhou Guangdong, China. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 24, 2016. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Guangdong Dexin Sports Industry Co.,ltd
FDA registration number
3014167550
Address
Xinzhuang Section, Furong Road, Huadu District, Guangzhou Guangdong, China, 510850
Owner or operator
GUANGDONG DEXIN SPORTS INDUSTRY CO.,LTD (10086739)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer
First device listed
December 7, 2022
Registered through
2026
Brand names listed
Bevo Comfort PPE Goggle White S/M, L/XL, 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, CAP SURGICAL, Cover, shoe, operating- room, DEX24,DEX25,DEX26,DEX27,DEX28, Diving Mask, Full Face Mask, Gown and more

Devices it lists

DeviceProduct codeClassRoleSource
Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement PolicyQOZNManufactureraccessdata.fda.gov
Cap, SurgicalFYF1Contract manufacturer, Exporter to the US, Manufacturer, Remanufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Contract manufacturer, Exporter to the US, Manufacturer, Remanufactureraccessdata.fda.gov
Lens, Spectacle, Non-Custom (Prescription)HQG1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Contract manufacturer, Exporter to the US, Manufacturer, Remanufactureraccessdata.fda.gov
Non-Surgical GownOEA1Contract manufacturer, Exporter to the US, Manufacturer, Remanufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Exporter to the US, Manufactureraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the US, Manufactureraccessdata.fda.gov
Shield, Eye, RadiologicalIWS1Exporter to the US, Manufactureraccessdata.fda.gov
Strip, Temperature, Forehead, Liquid CrystalKPD2Contract manufacturer, Exporter to the US, Manufacturer, Remanufactureraccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 24, 2016K160802Infrared Forehead Thermometer, FT-100AFLLSubstantially EquivalentHangzhou Universal Electronic Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 24, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.