Is your device manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non- viable or rendered non-viable

 
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Non-viable means not capable of living, growing, developing, or functioning successfully.

Is your device intended to come into contact with intact skin only?

 
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Intact skin is healthy skin in which there are no breaks, scrapes, cuts, or abnormal openings that allow pathogens to enter.