NEWEL HEALTH S.R.L.

Newel Health S.R.L. specializes in digital medical devices under the AMICOMED brand. These devices are designed for monitoring and managing chronic diseases, providing data-driven solutions for continuous patient tracking and remote health assessment. The focus is on leveraging technology to improve long-term care and outcomes for patients with ongoing health conditions.

Newel Health S.R.L. is headquartered in Italy. The company’s location in Italy aligns with its compliance framework for manufacturing and distributing medical devices within the European Union, ensuring adherence to regional regulatory standards.

Newel Health S.R.L.’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. This registry ensures transparency and traceability of devices placed on the EU market, including their classification and compliance status.

Newel Health S.R.L.’s devices fall under EU Class IIa, which is the second-lowest risk classification for medical devices in the European Union. This classification is assigned based on factors like the device’s intended use, potential risks, and the body’s interaction with it. Class IIa devices require conformity assessment procedures to ensure safety and performance before market placement.