smilesonica.com

smilesonica.com manufactures two primary devices: the Aevo System, an ultrasound device specifically designed for imaging the oral cavity, and the Aevo Oral Ultrasound gel, which improves imaging quality by enhancing acoustic coupling between the device and the patient’s skin or oral tissues. These products are tailored for dental and oral health applications.

smilesonica.com is based in Canada. While the company’s headquarters and primary operations are located there, its devices are registered in the EUDAMED database, indicating compliance with European Union regulatory requirements for medical devices. This suggests international market engagement, particularly in the EU.

The Aevo System and Aevo Oral Ultrasound gel are classified as Class IIa devices under EU regulations. This classification is based on their intended use—non-invasive imaging and acoustic coupling—and their associated risk profile, which requires conformity assessment procedures like design examinations and clinical evaluations before market placement.

Yes, both the Aevo System and Aevo Oral Ultrasound gel are registered in the EUDAMED database. This registry is the official EU portal for tracking medical devices, ensuring transparency about their regulatory status, manufacturer details, and compliance with EU directives like MDR (Medical Device Regulation). Listing here is mandatory for devices placed on the EU market.