What products are included in medical devices? - Shenzhen Jiayuanda Technology Professional Welding Medical Device
Time:09/27/2021 Views:1 What products are included in medical devices?
Medical devices refer to instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials and other similar or related articles, including the required computer software, which are directly or indirectly used in the human body.
The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; The examination, substitution, adjustment or support of physiological structures or processes; Life support or maintenance; Pregnancy control; Examination of samples from the human body to provide information for medical or diagnostic purposes.
Second, what is the "third class medical devices"?
Category III medical devices are the highest level of national medical devices. They refer to the medical devices implanted into the human body to support and maintain life, which are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.
The third category of medical instruments are: implantable cardiac pacemaker, extracorporeal shock wave lithotripter, patient invasive monitoring system, iOL, invasive endoscope, ultrasonic scalpel, color ultrasonic imaging equipment, laser surgery equipment, high-frequency electric knife, microwave therapeutic instrument, medical magnetic resonance imaging equipment.
X-ray therapy equipment, X-ray machine over 200mA, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valve, artificial kidney, respiratory anesthesia equipment, disposable sterile syringes, disposable infusion set, blood infusion set, CT equipment, etc.