What is the meaning of Balsamane class II medical device

Medical devices for which the safety and effectiveness of Balsamans should be controlled. Class II medical device means, on its safety, effectiveness should be controlled medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry instrument are classified as Class II medical devices. Bazaarman is a brand registered and established in the Chinese Trademark Office, so that Bazaarman Class II medical device means that the safety and effectiveness of Bazaarman should be controlled medical devices.