Equipment refers to instruments, devices, apparatus, 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.

Equipment and medical consumables are included.

Effectiveness is primarily achieved through physical means, not via pharmacology, immunology, or metabolism, or even though these methods may be involved, they only serve as auxiliary.

The purpose is for the diagnosis, prevention, monitoring, and relief of diseases; for the diagnosis, monitoring, relief, or functional compensation of injuries; for the examination, substitution, regulation, or support of physiological structures or processes; for the support or maintenance of life; for pregnancy control; and for providing information for diagnostic purposes by examining samples from the human body.