It is not a medical device, medical device, refers to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software; its utility is mainly obtained through physical and other means, rather than through pharmacological, immunological or metabolic means, or although these means are involved, but only plays a ancillary; and which are intended for:
(i) diagnosis, prevention, monitoring, treatment, or mitigation of disease;
(ii) diagnosis, monitoring, treatment, mitigation, or functional compensation of injury;
(iii) testing, substitution, modulation, or support of physiological structures or processes;
(iv) support or maintenance of life;
(v) pregnancy control;
(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.