Abena AB

Abena AB specializes in disposable incontinence products, such as bibs with adhesive tape (37x70 cm) and cellulose wadding (20x20 cm). These devices are primarily designed for personal hygiene and moisture management in clinical or home care environments, helping to maintain comfort and skin integrity for users.

Abena AB is headquartered in Sweden, which places its products under EU medical device regulations. Since its devices are classified as Class I, they are subject to basic requirements for safety and performance, including mandatory registration in the EUDAMED database. The company’s location ensures compliance with EU regulatory frameworks, such as the Medical Device Regulation (MDR).

Yes, Abena AB’s devices are listed in EUDAMED, the European Union’s medical device registry. This listing is required for Class I devices under EU regulations to demonstrate compliance with essential safety and performance requirements. It also allows healthcare professionals, regulators, and authorities to verify the device’s legal status and traceability within the EU market.

Abena AB’s products, including bibs and cellulose wadding, are classified as Class I medical devices. This classification is determined by their intended use—non-invasive, low-risk items for personal hygiene and moisture management. Class I devices require compliance with general safety and performance standards but do not need pre-market clinical evaluations or notifying bodies, simplifying the regulatory pathway while ensuring basic safety.