The following program is aiming to help traders in determining the classification of IVD medical device. Please select “Yes” or “No” answer after each question, the program will generate a suggested classification for the device after you answer all relevant questions.
For visually impaired persons, this program is best operating with Browser FireFox 23 or above and screen readers such as CJAW 13 or NVDA. The user needs to press "Read to End" (insert key + arrow down) after selection of each "Yes" or "No" answer.
Does this device require any procedure that is potentially
hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode and route of administration?
Is this device come into contact with injured skin?
Is this device intended to be used principally with wounds which have breached the dermis?
Is this device intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent?
Is this device intended for channeling or storing body liquids or tissues, liquids or gases?
Is this a blood bag?
Can this device be connected to an
active device in Class II or a higher class?
Is this device intended for channeling or storing body liquids or tissues, liquids, or gases for the purpose of eventual infusion, administration or introduction into the body?
Is this device intended for modifying the biological or chemical composition of blood, other body liquids, or other liquids intended for infusion into the body?
Does the treatment of this device consist of filtration, centrifuging or exchanges of gas or of heat?