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  1. #2569823

    Chomh maith leis sin, léireofar go soiléir leis na treoracha úsáide nár cheart an fheiste a úsáid i gcás créachtaí oscailte ná gríos, ná réigiúin ata, dhearga, ghreannaithe, ionfhabhtaithe nó athlasta ná grís craicinn, ina dtiocfaidh comhchodanna den fheiste i dteagmháil leis na réigiúin sin.

    The instructions for use shall also clearly indicate that the device is not to be used in case of open wounds or rashes, or swollen, red, irritated, infected, or inflamed areas or skin eruptions, where components of the device will come into contact with these areas.

    Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance)