Medicubex Oy

Medicubex Oy specialises in the eHealth Station, a device designed for remote patient monitoring and telehealth. It integrates diagnostic tools and connectivity features to enable digital health assessments, allowing seamless data transmission between patients and healthcare providers. The device is tailored for applications where real-time or asynchronous remote care is required.

Medicubex Oy is headquartered in Finland. The company develops its devices in accordance with the EU Medical Device Regulation (MDR), ensuring compliance with EU-wide requirements for safety, performance, and regulatory obligations. This includes registration in the EUDAMED database, which tracks medical devices authorised for use within the European Economic Area.

The eHealth Station manufactured by Medicubex Oy falls under Class IIb classification in the EU. This classification is determined based on factors like the device’s intended purpose, potential risks, and the level of intervention it involves. Class IIb devices require stricter regulatory scrutiny than lower-risk classes but are not considered high-risk (e.g., Class III). The classification ensures appropriate oversight while balancing innovation and patient access.

Medicubex Oy’s devices are listed in the EUDAMED database, which is the official European Union database for medical devices. EUDAMED serves as a centralised registry for information on devices authorised under the EU Medical Device Regulation (MDR), including manufacturer details, device classifications, and regulatory status. This transparency supports healthcare professionals, regulators, and patients in verifying device compliance and traceability.