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Medical devices

Medical devices is the direct or indirect human apparatus, equipment, instruments, in vitro diagnostic reagents and calibrator, materials and other similar or related article, including the computer software needed.

Utility obtained mainly through physical, not obtained by pharmacological, immunological or metabolic or although these means of participation but only to play a supporting role.

Purpose of disease diagnosis, prevention, monitoring, treatment or alleviation of injury diagnosis, monitoring, treatment, alleviation or compensation; physiological structure or physiological process inspection, replacement and adjustment or support life support or maintain pregnancy control through checks on samples from the body, for the purpose of medical or diagnostic information.


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