FDA 510(k)

We are pleased to announce that we have successfully completed the Establishment Registration & Device Listing process with the FDA, further strengthening our commitment to the U.S. market.

This milestone follows the FDA 510(k) clearance received in 2021, which confirmed the safety and effectiveness of our MAPP® solution.

To ensure ongoing compliance and communication with the FDA, we have appointed a U.S. Agent, enabling us to place our solutions on the U.S. market.