EPI ADVANCED MEDICINE S.L.

EPI Advanced Medicine S.L. specializes in the EPI® ALPHA, a medical device specifically designed for the emergency administration of epinephrine. This is used primarily in cases of severe allergic reactions or anaphylaxis, where rapid intervention is critical.

The company is headquartered in Spain, as indicated by its registration details. This location aligns with its participation in the EU’s regulatory framework for medical devices.

The EPI® ALPHA device is registered in the EU’s eudamed database, which serves as the centralised registry for medical devices within the European Union. This ensures compliance with EU regulations and transparency in the device’s lifecycle.

The EPI® ALPHA is classified as a Class IIa medical device under EU regulations. This classification is determined by factors such as the device’s intended purpose, potential risks, and the level of intervention it provides. Class IIa devices require stricter conformity assessment procedures than Class I but are not as high-risk as Class IIb or III devices.