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ADDITIONAL INFORMATION FOR HEALTHCARE PROFESSIONALS

Please note that no conformity assessment procedure according to the MDR has yet been carried out for baroloop, and therefore the product is not yet marketable. Furthermore, baroloop can only be provided and used once conformity with the MDR has been successfully established and it has received the corresponding certification. In addition, we would like to point out that both the further development of baroloop and the conformity assessment procedure may fail.