Because the disposable pulse flusher needs to contact the wound, it will have a relatively large impact on the human body, but it does not need to be implanted in the human body, and it is relatively lower than the higher-level medical device products. According to my country's medical device classification standards, The risk of medical device products is moderate, and strict control and management are required to ensure that the product is effective and effective. Medical device products belong to the second class of medical devices, so the disposable pulse flusher is also classified as the second class of medical devices.
If it is a Class III medical device, it refers to a medical device that needs to be implanted into the human body; is used to support and sustain life; has the potential danger to the human body, and its safety and effectiveness must be strictly controlled.
The above is the relevant introduction to the disposable pulse flusher, I hope the content of this article will be helpful to you.