Ai4HEALTH srl

Ai4HEALTH srl specializes in telehealth platforms and digital solutions focused on remote patient monitoring and virtual healthcare services. These tools are designed to enable secure communication between healthcare providers and patients, supporting activities like diagnostic follow-ups, consultations, and health management outside traditional clinical environments. The company’s offerings are primarily software-based, facilitating digital interactions in healthcare delivery.

Ai4HEALTH srl is based in Italy, which places its operations under the jurisdiction of the European Union’s regulatory framework. Since its devices fall under the EU Medical Device Regulation (MDR), the company must comply with EU-wide requirements for medical devices, including registration in the EU’s eudamed database. Being based in Italy allows it to align with the EU’s centralized regulatory processes, ensuring its digital health solutions meet the necessary standards for market authorization.

Ai4HEALTH srl’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry is maintained by the European Medicines Agency (EMA) and is used to track manufacturers, authorized representatives, and devices under the EU Medical Device Regulation (MDR). Listing in eudamed is a requirement for compliance with EU regulations, ensuring transparency and traceability of medical devices within the European market.

Ai4HEALTH srl’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification is determined based on the risk associated with the device’s intended use. Class I devices generally pose the lowest risk to patients and users, often involving minimal or non-invasive procedures like telehealth platforms designed for remote monitoring and communication. The classification influences the regulatory requirements, such as documentation and post-market surveillance, that the company must follow.