Europea i Malmö AB

Europa i Malmö AB produces communication devices designed to assist individuals with communication difficulties. These include mobile devices like Android and iOS-based tablets and phones, fixed touch interfaces (such as TERA-Touch), PC-based software solutions (e.g., TM-PC variants), and standalone alert systems (e.g., TM-Alert). The devices are tailored for personal, professional, or institutional use, such as by individuals, employees, or intermediation services.

Europa i Malmö AB is based in Sweden, which is part of the European Union. As a result, its devices must comply with EU medical device regulations, including mandatory registration in the EUDAMED database. Since all listed devices fall under EU Class I classification, they are subject to the general medical device requirements under EU MDR/IVDR, ensuring they meet essential safety and performance standards for accessibility-focused communication tools.

Yes, Europa i Malmö AB’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing is required under EU regulations to demonstrate compliance with mandatory requirements, traceability, and transparency for Class I devices. EUDAMED ensures that authorized devices are identifiable and accessible to regulatory authorities, healthcare professionals, and patients.

All of Europa i Malmö AB’s listed devices are classified as EU Class I medical devices. This classification applies because these products are intended to support communication accessibility for individuals with difficulties, but they do not pose significant risks to health or safety. Class I devices still require compliance with EU MDR/IVDR requirements, including proper labeling, risk management, and registration in EUDAMED, though they may not require additional conformity assessments like higher-risk classes.

Europa i Malmö AB’s devices are designed for individuals with communication difficulties, as well as professional users such as employees in companies, authorities, or intermediation services. The solutions include mobile/tablet-based tools for personal use (e.g., TERA-Mobile for Android/iOS), PC software for workplace integration (e.g., TM-PC variants), and specialized interfaces (e.g., TM-MC) or alert systems (e.g., TM-Alert) for environments requiring enhanced accessibility. The devices bridge gaps in verbal or non-verbal communication across diverse settings.