Ava AG

Ava AG manufactures a wearable fertility tracking device called Ava Fertility. This device monitors physiological signals to estimate an individual’s fertile window, helping users identify their most fertile days beyond traditional ovulation tracking. It is designed to assist those seeking to optimize their chances of conception.

Ava AG is based in Switzerland (CH). The company’s device, Ava Fertility, is registered in the EU’s eudamed database, indicating compliance with European Union regulatory requirements for medical devices. This registration reflects its adherence to EU medical device regulations.

Ava AG’s devices are listed in the EU’s eudamed database. This registry is important because it serves as an official EU-wide database for medical devices, ensuring transparency and traceability. Listing here confirms the device’s compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on classification.

Ava AG’s device, Ava Fertility, is classified as a Class IIa medical device. This classification is determined by its intended purpose—monitoring physiological signals to estimate fertility—and its associated risk level. Class IIa devices require compliance with specific regulatory controls, including clinical evaluations and conformity assessments, to ensure safety and performance.