6840 medical devices include what

6840

Clinical testing and analyzing instruments

Serial number

Name

Name

Name

Product

Name Examples

Management category

1

Blood analysis system

Blood analyzer, blood type card

Ⅲ

Full-automatic hematology analyzer, full-automatic smear machine, semi-automatic Hematocrit Analyzer, Semi-automatic Thrombus and Coagulation Analyzer, Automatic Blood Bank System, Hemoglobin Analyzer, Platelet Aggregator, Blood Glucose Analyzer, Blood Rheometer, Blood Viscometer, Red Blood Cell Deformer, Blood Rheology Parameter Tester, Thromboelastometer, Flow Cytometry Analyzer, Fully Automated Thrombus Stopping and Hemostasis Analyzer, Fully Automated Coagulation and Fibrinolysis Analyzer

Ⅱ

2

Biochemical Analysis System

Automatic Biochemical Analyzer, Automatic Rapid (Dry) Biochemical Analyzer, Automatic Multi-Electrolyte Analyzer, Semi-Automatic Biochemical Analyzer, Semi-Automatic Mono/Multi-Electrolyte Analyzer

3

Immunoassay System

Automatic Immunoassay Analyzer

III

Enzyme Immunoassay Instrument

Semi-automatic Enzyme Labeler, Fluorescence Microscopy System, Specific Protein Analyzer, Chemiluminescence Analyzer, Fluorescence Immunoassay Analyzer,

II

4

Bacterial Analyzing System

Mycobacterium Tuberculosis Analyzer, Pharmacovigilance Analyzer

III

Bacterial Determination System, Rapid Bacterial Cultivation Instrument, H. pylori Analyzer

II

5

Urine Analysis System

Automatic Urine Analyzer and Test Strips

II

6

Biological Separation System

Automatic Electrophoresis Instrument, Capillary Electrophoresis Instrument, Isoelectro Focusing Electrophoresis Instrument, Nucleic Acid Purification Analyzer, Low-, Medium- and High-High-Pressure Electrophoresis Instrument, and Cellular Electrophoresis Instrument

7

Blood Gas Analyzer System

Blood Gases Analyzer

Blood Gases Analyzer

Automatic Blood Gases Analyzer

Automatic Blood Gas Analyzer, Tissue Oxygen Content Measuring Instrument, Blood Gas Collector, Blood Oxygen Saturation Tester, CO2 Infrared Analyzer, Transcutaneous Oxygen Partial Pressure Monitor, Blood Gas Acid-Base Analyzer, Electrochemical Oxygen Analyzer

8

Gene and Life Science Instruments

Full-automatic Medical

PCR Analyzer System

III

Sperm Analyzer, Biochip Reader,

PCR Amplifier

II

10

Clinical Medical Testing Auxiliary Equipment

Ultra-clean Device, Blood Cell Counting Plate, Automatic Sample Filling System, Automatic Sample Injector System, Plate Washer

II