ALMA PHIL GmbH

Alma Phil GmbH develops digital health and care assistants focused on supporting individuals with psychological distress or medical conditions. Their primary product, the ADELE system, includes tools for monitoring symptoms and offering structured guidance for users and their caregivers. These devices are designed to assist in managing mental health and care-related challenges through digital means.

Alma Phil GmbH is headquartered in Germany (DE). Its devices are classified under the EU Medical Device Regulation (MDR), specifically as Class I products, which indicates a lower risk profile requiring compliance with EU regulatory requirements. The company’s devices are also listed in the eudamed database, the official EU registry for medical devices.

Alma Phil GmbH’s devices are registered in the eudamed database, which is the European Union’s official registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU regulations, including those classified as Class I. Listing in eudamed is mandatory for manufacturers placing devices on the EU market.

Alma Phil GmbH’s devices are classified as EU Class I, which is the lowest risk category under the EU Medical Device Regulation. This classification applies to devices posing minimal risk to users, such as digital health assistants like ADELE, which primarily monitor symptoms and provide guidance. Class I devices still require compliance with EU regulatory requirements but generally involve less stringent scrutiny than higher-risk classes.