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Data / Medical devices / China / Contec Medical Systems Co., Ltd

Contec Medical Systems Co., Ltd: FDA-registered device maker in Qinhuangdao Hebei, China, 20 510(k) clearances

Contec Medical Systems Co., Ltd is registered with the FDA (registration 3006979678) in Qinhuangdao Hebei, China. It lists 22 device types. The FDA files 20 510(k) clearances under its listings, the newest dated June 14, 2024. 1 recall event names it as the recalling firm. 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.

Get makers like this oneWatch Contec Medical Systems Co., Ltd
FDA registration number
3006979678
Address
No.112 Qinhuang West Street Economic and Technical Development Zone, Qinhuangdao Hebei, China, 066004
Owner or operator
CONTEC MEDICAL SYSTEMS CO., LTD (10025156)
Roles
Manufacturer
First device listed
December 2, 2008
Registered through
2026
Brand names listed
2MHz CW Water Proof Probe; 2MHz Normal Probe; 3MHz CW Normal Probe; 3MHz CW Water Proof Probe;, ABPM50 Automatic Blood Pressure Monitor, ABPM50 Automatic Blood Pressure Monitors, Baby Sound A Pocket Fetal Doppler, Baby Sound B Pocket Fetal Doppler, Baby Sound C Pocket Fetal Doppler, CMS1700B Color Doppler Ultrasound Diagnostic System, CMS1700C Color Doppler Ultrasound Diagnostic System and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Manufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Manufactureraccessdata.fda.gov
ElectrocardiographDPS2Manufactureraccessdata.fda.gov
Electrocardiograph, Ambulatory, With Analysis AlgorithmMLO2Manufactureraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Manufactureraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Manufactureraccessdata.fda.gov
Monitor, Ultrasonic, FetalKNG2Manufactureraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Manufactureraccessdata.fda.gov
OximeterDQA2Manufactureraccessdata.fda.gov
Oximeter, Infrared, Sporting, AviationOCH2Manufactureraccessdata.fda.gov
Oximeter, WellnessPGJ2Manufactureraccessdata.fda.gov
Stethoscope, ManualLDE1Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.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
June 14, 2024K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)KNGSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
May 3, 2024K232895B-Ultrasound Diagnostic SystemIYOSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
May 2, 2024K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)IYNSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
September 28, 2022K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNGSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
April 28, 2021K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure MonitorDXNSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
December 18, 2020K201980Infrared ThermometerFLLSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
January 22, 2018K171360CONTEC™ ElectrocardiographDPSSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
November 17, 2017K170856CMS600P2 B-Ultrasound Diagnostic SystemIYOSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
May 30, 2017K170954Portable ECG MonitorDPSSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
June 22, 2016K152863Portable ECG MonitorDPSSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
March 5, 2014K131900CONTEC ELECTROCARDIOGRAPHDPSSubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
September 30, 2011K101273DYNAMIC ECG SYSTEM MODEL TLC5000MLOSubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
July 27, 2011K110156AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,DXNSubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
June 28, 2011K101692PATIENT MONITORMHXSubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
May 13, 2011K110775ELECTRONIC SPHYGMOMANOMETERDXNSubstantially EquivalentContec Medical Systems Co.,Ltdaccessdata.fda.gov
May 13, 2011K110774ELECTRONIC SPHYGMOMANOMETERDXNSubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
June 11, 2010K101127PATIENT MONITOR, MODEL PM50MWISubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
June 11, 2009K090671PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60DDQASubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
February 25, 2009K082480CONTEC POCKET FETAL DOPPLERKNGSubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
November 10, 2008K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQASubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 10, 202596046Class IIOngoingCMS8000 Patient MonitorPatient monitor has nine identified cybersecurity vulnerabilities.accessdata.fda.gov

Compare with other makers

Updated May 14, 2025. 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.