An instrument, apparatus, appliance, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, the intended use of which is by the manufacturer to be used in human beings for one or more of the following specified purposes, either alone or in combination. These purposes are:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation or compensation of injury
-. -Study, substitution, regulation, or support of anatomical or physiological processes
-Support or maintenance of life
-Pregnancy control
--Sanitization of medical devices
--Provision of medical information by means of in vitro examination of samples taken from the human body
The primary design effect of its action on the surface of or in the body is not obtained by pharmacological, immunological, or metabolic