According to the Regulation on the Supervision and Administration of Medical Devices, the second category of medical devices refers to medical devices, diagnostic reagents and other medical devices suitable for in vivo or in vitro, including but not limited to electrocardiographs, ultrasonic diagnostic instruments, blood glucose meters, infusion sets, syringes, catheters, etc. The medical care package belongs to an integrated medical tool composed of medical materials and instruments, and some of them are equipped with second-class medical instruments, such as alcohol cotton balls, adhesive tapes and abdominal belts. And it also belongs to the second class of medical devices.
According to China's "Regulations on the Supervision and Administration of Medical Devices", medical devices are divided into class I, class II and class III. The specific classification criteria are determined by the food and drug supervision department according to the use risk level, medical indications, functions and safety.