What does Class II medical device mean?

Medical devices are divided into three categories, I think you should be talking about Class II, not Class II

The first category refers to the routine management is sufficient to ensure the safety and effectiveness;

The second category refers to the product mechanism has been internationally and domestically recognized, the technology is mature, the safety and effectiveness of the product must be controlled;

The third category refers to implanted in the human body, or used for life support, or complex technical structure, may be potentially dangerous to the human body, safety and effectiveness must be strictly controlled. Or complex technical structure, the human body may be potentially dangerous, safety and efficacy must be strictly controlled