Class III medical device is the highest class of medical devices in the country, refers to the implantation of the human body, used to support, maintain life, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
Class III medical devices are: implantable cardiac pacemakers, extracorporeal shockwave lithotripters, invasive patient monitoring systems, artificial crystals, invasive endoscopes, ultrasound scalpels, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpels, microwave therapeutic instrument, medical nuclear magnetic **** vibration imaging equipment.
X-ray therapeutic equipment, X-ray machines above 200mA, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valves, artificial kidney, respiratory anesthesia equipment, disposable sterile syringes, disposable infusion sets, blood transfusion sets, CT equipment.
Extended information:
Production of Class III medical devices should be clinically validated. As said the production of class III medical devices, by the State Council drug supervision and management department for examination and approval, and issued a certificate of registration for the production of products. The state of the third class of medical devices safety and effectiveness of strict control management.
There are a lot of hemostatic gauze, soluble hemostatic gauze on the market, but only the third class can be implanted in the body, absorbed by the body, do not have to take out, the second class hemostatic gauze can only be used for the surface of the body, although the second class of manufacturers to publicize can be used in the body, but is not in line with the law, but also prone to problems.
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