Serial number
Name
Name
Product
Name Examples
Management category
1
Therapeutic and first aid devices for the heart
Implantable cardiac pacemakers, external cardiac pacemakers, defibrillators, cardiac pacemakers, Intra-aortic capsule counterpulsators, defibrillating pacemakers
III
2
Invasive electrophysiological devices and innovative electrophysiological devices
Extracorporeal shock wave lithotripter, invasive patient monitoring system, intracranial pressure monitor, invasive cardiac output meter, invasive multicontact physiological recorders, intracardiac Hippocampal beam electrocardiographs, intra- and extra-endocardial endocardial mappings, and invasive electronic sphygmomanometers.
III
3
Invasive Medical Sensors
Various Implanted Medical Sensors
III
Noninvasive Medical Sensors
II
4
Diagnostic Cardiology Instruments
Single-conductor Electrocardiography (ECG) machines, Multi-conductor Electrocardiography (MEC) machines, Fetal Electrocardiography (FET) machines, Electrocardiography (ECG) machines, Comprehensive Cardiac Vector Mapping machines, Electrocardiography machines, and Electrocardiography machines. Vector Mapping Machine, ECG Comprehensive Tester, Late Potential Tester, Non-invasive Cardiac Function Tester, Heart Rate Variability Tester, ECG Analyzer, Exercise ECG Function Meter, ECG Multiphase Analyzer, ECG Telemetry Instrument, ECG Telephone Delivery System, Real-Time Rhythm Analyzer and Recorder, Long-Range ECG Recorder, ECG Labeling Mapper, ECG Workstation
II
5
Electroencephalography diagnostic instruments
Electroencephalography machine, brain resistivity meter, brain wave analyzer, brain topography mapper, EEG real-time analyzer and recorder
II
6
Electromyography diagnostic instruments
Electromyography machine
II
7
Other bioelectrical diagnostic instruments
Eyetracking instrument, Nystagmograph, electroretinograph, evoked potential detection system (including visual, auditory and physical)
II
8
Electroacoustic diagnostic instruments
Audiometer, pediatric audiometer, cardioplegia, tonometry, gastrogram, gastrointestinal galvanometer
II
9
Non-invasive monitoring equipment
Arrhythmia analyzers and alarms, monitors with S-T segments
III
Patient monitors (monitoring parameters including electrocardiography, oxygen saturation, non-invasive blood pressure, pulse, temperature, respiration, end-expiratory carbon dioxide), anesthesia gas monitors, respiratory function monitors, sleep evaluation systems, labor and delivery monitors
II
10
Respiratory Function and Gas Analysis Measurement Device
Comprehensive Lung Function Measuring Instrument, Respiratory Function Tester, Oxygen Concentration Measuring Instrument, Pulmonary Ventilation Function Tester, CO2 Concentration Measuring Instrument, Intra-Lung Gas Distribution Function Tester, Diffusion Function Tester, Nitrogen Meter, Micro Gas Analyzer, Pressure-type Volumetric Depiction Instrument, Lung Volumetric Instrument
II
11
Medical Stimulators
Cardiac Workstation Electrical Stimulators
III
Acoustic, Optical, Electrical and Magnetic Stimulators
II
12
Blood Flow and Volume Measurement Devices
Cerebral Hemodynamic Mapper, Impedance Hemodynamic Mapper, Electromagnetic Blood Flow Meter, Non-invasive Cardiac Output Meter, Comprehensive Cardiac and Vascular Function Testers<
II
13
Electronic pressure determination device
Electronic blood pressure pulsometer, dynamic blood pressure monitor
II
14
Physiological research experimental instruments
Square wave physiology instrument, bioelectrical impulse frequency analyzer, bioelectrical pulse analyzer, microelectrode controller, micro-manipulator, Microelectrode monitor
II
15
Spectral diagnostic equipment
Medical infrared thermography, infrared breast diagnostic instrument
II
16
Extracorporeal counterpulsation and its auxiliary circulatory devices
Balloon external counterpulsation devices
III
17
Sleep Apnea Therapy System
II
18
Electrocardiographic Electrodes
II
20
Electrocardiographic lead wires
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