Refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software.
The utility is mainly obtained through physical methods, not through pharmacology, immunology, or metabolism, or although these methods are involved but only play an auxiliary role.
The purpose is the diagnosis, prevention, monitoring, treatment or alleviation of diseases; diagnosis, monitoring, treatment, alleviation or functional compensation of injuries; inspection, replacement, adjustment or support of physiological structures or physiological processes; life support or maintenance; pregnancy control; Provide information for medical or diagnostic purposes by examining samples from the human body.
