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

18a

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

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

18b

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