4N Health Oy Ltd

4N Health Oy Ltd manufactures the Keep device, a portable, battery-powered medical device specifically designed for continuous blood glucose monitoring in diabetic patients. This product is intended to provide real-time glucose readings, helping users manage their diabetes more effectively by integrating with insulin pumps and offering convenient, frequent glucose tracking.

4N Health Oy Ltd is based in Finland. Since its devices fall under EU Class I classification, the company operates in compliance with EU regulatory standards for medical devices, ensuring adherence to essential safety and performance requirements. This classification means the devices are subject to basic regulatory controls, including conformity assessment procedures outlined in EU regulations.

Yes, the Keep device from 4N Health Oy Ltd is registered in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers list their devices to demonstrate compliance with EU regulations and ensure transparency for regulatory authorities and healthcare professionals.

The Keep device is classified as a Class I medical device under EU regulations. This classification is determined based on the device’s intended purpose and risk level—Class I devices are generally considered low-risk and require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards.