Skip to the page

Data / Medical devices / China / Zhongshan GL Electronics Co.,ltd

Zhongshan GL Electronics Co.,ltd: FDA-registered device maker in ZHONGSHAN Guangdong, China, 1 510(k) clearance

Zhongshan GL Electronics Co.,ltd is registered with the FDA (registration 3017858989) in ZHONGSHAN Guangdong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3017858989
Address
3rd Floor, Wanhua Building, Dehe Road, Jidongyi, Xiaolan Town, Zhongshan City, ZHONGSHAN Guangdong, China, 528416
Owner or operator
ZHONGSHAN GL ELECTRONICS CO.,LTD (10078645)
Roles
Contract manufacturer, Manufacturer
First device listed
April 25, 2022
Registered through
2026
Brand names listed
100001971 Nasal aspirator, 3-IN-1 Humidifier+diffuser, model 09500900, 3-IN-1 Humidifier+diffuser, model 09500901, 3-IN-1 Humidifier+diffuser, model 09500902, 3-IN-1 Humidifier+diffuser, model 100001970, 3-IN-1 Humidifier+diffuser, model 100001988, 3-IN-1 Humidifier+diffuser, model 100001989, 50001 Insect bite healer and more

Devices it lists

DeviceProduct codeClassRoleSource
Bottle, Collection, VacuumKDQ2Contract manufacturer, Manufactureraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Pad, Heating, PoweredIRT2Contract manufacturer, Manufactureraccessdata.fda.gov
Piezo-Electric Stimulator For Relief Of Mosquito Bite ItchOSG2Contract manufacturer, Manufactureraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Manufactureraccessdata.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
October 7, 2026K262822Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)BTASubstantially EquivalentZhongshan GL Electronics Co. , Ltd.accessdata.fda.gov

Compare with other makers

Updated October 7, 2026. 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.