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Certifications

The CE certification of FLOWer, a Class III medical device obtained in full compliance with the Medical Device Regulation (MDR), will allow for the production and commercialization of the device throughout the European territory.

AorticLab has obtained ISO13485 certification for the design and development of its products. It certifies that AorticLab has established and is maintaining a quality management system, which meets the requirements of the standard.