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November 2, 2022

Lunaris : launch on the European medical devices market

Axiles Bionics' Lunaris and IO Charger are now compliant with the European medical device regulation, opening doors to the European market.

Lunaris prosthesis on a certification test bench

After many months of intensive in-house and laboratory development, the Lunaris and its IO Charger have now been officially validated and declared compliant with the European regulatory requirements for medical devices.

This opens the doors to the European market, positioning Axiles Bionics as a medical device manufacturer in all countries of the European Union.

Registration with the Federal Agency for Medicines and Health Products (FAMHP) confirms the success of this major step.

European conformity
Medical Device
AFMPS

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