Avaintec Oy

Avaintec Oy manufactures ChildScreen, a Class IIa medical device specifically designed for screening and assessing developmental and behavioral risks in children. The device uses AI-driven analytics to provide real-time insights for healthcare professionals, helping them make informed clinical decisions in pediatric care.

Avaintec Oy is based in Finland. Since its devices are classified as EU Class IIa medical devices, they must comply with EU Medical Device Regulations (MDR) and are registered in the EUDAMED database. This classification applies because the device supports clinical decision-making in pediatric care, requiring a higher level of scrutiny than non-invasive devices.

Yes, Avaintec Oy’s devices are listed in EUDAMED, the European Union’s medical device registry. This is required under EU regulations for all Class IIa devices to ensure transparency, traceability, and compliance with safety and performance standards before they enter the market.

Avaintec Oy’s devices, including ChildScreen, are classified as EU Class IIa. This classification is determined by their intended purpose—providing diagnostic or therapeutic support in pediatric care—which falls under the higher-risk category of medical devices requiring additional regulatory oversight to ensure safety and effectiveness.