Mitteinvasiivne meditsiiniseade, mis puutub kokku vigastatud nahaga: ... 2) kuulub IIb klassi, kui see on mõeldud kasutamiseks peamiselt sellise haava puhul, mis on läbistanud derma ja mis võib kinni kasvada ainult teisespingsalt.
All non-invasive devices which come into contact with injured skin: ... are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent ...
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