Biotic Phocea was the first company to offer, in 2000, an ink for medical purposes with status as a CE class IIb medical device, sterilized using an industrially validated method, for single use.
The company was already ISO9001-13485 certified. A wide range of "flesh" and "areola" colours allowed the safe and easy-to-use single-use principle, which requires no mixing to obtain the correct colour, to be offered across the board.