Sequana Medical Receives EU’s MDR Certification for Its Implantable Alfapump

Ghent, Belgium-based Sequana Medical has received certification for its alfapump system as compliant with the EU Medical Device Regulation.

The device is a subcutaneously implanted, battery-operated pump that continually moves abnormal fluid buildup from the abdominal cavity to the bladder, where the waste substance is excreted naturally from the body.

The MDR certification was granted by BSI (the British Standards Institution), an official notified body empowered to do so by the EU.