Enterosgel is Medical Device Class IIa
Briefly, the product Enterosgel meets the definition of a device due to the fact that it is not metabolised by the body. It is a silicon based chemical and does not act or rely on its action by metabolic, pharmacological, immunological means. It passes through the body within 12 hours unchanged except for the adsorption of the toxins which it is designed to adsorb and remove.
Enterosgel belongs to a class of silicon-containing enterosorbents, the same class as different types of clays and zeolites, and amorphous silicon dioxide. It is interesting to note that silicon-containing materials rather than activated carbon should be considered the first enterosorbents, because the tradition of eating natural clays for improvement of well-being, jugulation of diarrhoea, and, possibly, for treatment of deficiency in microelements, goes back to bygone times, and as a phenomenon known as geophagia it is observed particularly in primates.
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