FDA 510(k)

16 September, 2024

We are pleased to announce that we have successfully completed the FDA Establishment Registration & Device Listing, enhancing our commitment with the U.S. market. This milestone comes after receiving our FDA 510(k) clearance in 2021, which validated the safety and effectiveness of our MAPP® Solution.

 To ensure compliance and ongoing communications with the FDA, we have appointed an U.S. Agent, qualifying us to leverage our solutions into the U.S. Market.