According to the intended use of the product, it should belong to. Please check whether it meets the definition in the medical device classification rules. 15): "Medical devices refer to instruments, equipment, appliances, materials or other articles used in the human body alone or in combination, including required software; Its effects on human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; Its purpose is to achieve the following expected purposes:
(1) Prevention, diagnosis, treatment, monitoring and mitigation of diseases;
(2) Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability;
(3) research, substitution and adjustment of anatomical or physiological processes;
(4) Pregnancy control.
Its effects on human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role. "