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China Qingdao Bright Medical Manufacturing Co.,ltd.: FDA-registered device maker in Qingdao Shandong, China, 2 510(k) clearances

Name: China Qingdao Bright Medical Manufacturing Co.,ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

China Qingdao Bright Medical Manufacturing Co.,ltd. is registered with the FDA (registration 3007048259) in Qingdao Shandong, China. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 1, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007048259
Address: No.1 Tiankang Road Chengyang District, Qingdao Shandong, China, 266107
Owner or operator: China Qingdao Bright Medical Manufacturing CO.,Ltd. (10025835)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: May 13, 2008
Registered through: 2026
Brand names listed: BRAINSTREAM Disposable Deep Cup EEG Electrodes, Electrode.Electrocardiograph 40494E - Limb Clamp Electrode, Gel Electrode, OB-Tools Ltd., Qingdao Brgiht

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Device, Vein Location, Liquid Crystal	KZA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph, Multi-Function	MLN	2	Manufacturer	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Tester, Electrode/Lead, Electroencephalograph	GYA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Uterine Electromyographic Monitor	OSP	2	Exporter to the US, Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 1, 2020	K200540	BRAINSTREAM Disposable Deep Cup EEG Electrodes	GXY	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
August 6, 2015	K150398	EUM 100Pro	HGM	Substantially Equivalent	Ob Tools, Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 1, 2020. 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.