Mediseam Oy

Mediseam Oy specialises in vacuum-based medical devices designed for pressure injury prevention and limb immobilisation. Their product range includes shaped splints for legs, arms, and shins, vacuum mattresses for patient positioning, and pump systems to regulate pressure. These devices are primarily used in hospital and clinical settings to support patient care and mobility.

Mediseam Oy is based in Finland. Since their devices fall under EU Class I classification—reserved for low-risk, non-invasive products—they must comply with EU medical device regulations. This includes registration in the EUDAMED database, though compliance does not imply approval; it confirms their devices meet mandatory EU requirements for market placement.

Yes, Mediseam Oy’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. Listing there confirms their compliance with EU Class I requirements, though it does not guarantee individual device approval—only that they meet regulatory standards for non-invasive, low-risk products.

All Mediseam Oy devices are classified as EU Class I, meaning they are considered low-risk and non-invasive. This classification is based on their intended use—such as pressure injury prevention or limb immobilisation—where minimal risk to patients is involved. Class I devices still require compliance with EU directives but have fewer post-market surveillance obligations than higher-risk classes.