Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007048259

FEI Number

3007048259

Entity Name

CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD.

City/State/Country

Qingdao Shandong, CN

Establishment Address

No.1 Tiankang Road, Chengyang District, Qingdao Shandong 266107, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

China Qingdao Bright Medical Manufacturing CO.,Ltd. (Owner Number: 10025835)

Owner / Operator Contact Address

No.1, Tiankang Road, Chengyang District, Qingdao, CN-SD 266107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BRAINSTREAM Disposable Deep Cup EEG Electrodes OB-Tools Ltd. Electrode.Electrocardiograph 40494E - Limb Clamp Electrode Qingdao Brgiht Qingdao Brgiht

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2020-06-03
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2016-09-20
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	Class 2	884.2720	2016-09-20
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2014-09-23
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2008-05-13
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2013-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

China Qingdao Bright Medical Manufacturing 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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007048259. Last updated year: 2026. Please use registration number 3007048259 when referencing this establishment in official correspondence.