, in vitro diagnostic reagents and calibrators, materials, and other similar or related objects
used directly or indirectly in the human body, including the required computer software; the utility of which is mainly obtained by physical means
, not by pharmacological, immunological or metabolic means, or although
these means are involved but only play an auxiliary role; its purpose is:
(a) disease diagnosis, diagnosis, and metabolism, but only aided by these means.
These modalities are involved but only in an ancillary manner; the purposes of which are:
(i) diagnosis, prevention, monitoring, treatment, or mitigation of disease;
(ii) diagnosis, monitoring, treatment, mitigation, or compensation of function of an injury;
(iii) testing, substitution, modulation, or support of physiological structures or processes;
() life support or support for life;
(iv) support for life, or support for life. (iv) Life support or maintenance;
(v) Wavelength control;
(vi) Providing information for medical or diagnostic purposes
through the examination of samples from the human body.
The above is the definition of medical device, you judge for yourself