EBME Forums Forums Management Medical Equipment Management Electric suction units in cardio surgery = 2b ?

The manufacturer says: Commonly, these are in 2a Meddev, but in cardio surgery we classify them 2b. Is it normal?

I guess in cardiosurgery they're used invasively and peri-operatively - is this reason for IIb do you think? Classification is down to the intended purpose that's declared by the Manufacturer.