Orteam BV

Orteam BV specializes in mobility and rehabilitation aids. Their products include the Clawieter, a device designed for hand function training, the Verzorgingstafel Laag, a low care table for assisting patients during care tasks, and the BedBox, a modular bed system intended for clinical or home use. These devices are developed to enhance safety, mobility, and quality of life for individuals with disabilities.

Orteam BV is headquartered in Belgium, which is part of the European Union. Since its devices fall under EU medical device regulations, they are required to comply with EU standards and are registered in the EUDAMED database. This ensures traceability and transparency for regulatory oversight within the EU market.

Orteam BV’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry is mandatory for all Class I medical devices placed on the EU market, ensuring that manufacturers like Orteam BV meet regulatory requirements and maintain transparency for healthcare professionals and authorities.

Orteam BV’s devices are classified as EU Class I medical devices. This classification applies to products posing minimal risk, such as mobility aids and rehabilitation tools. Class I devices still require compliance with EU regulations, including conformity assessment procedures, but they do not always require third-party involvement unless they fall under specific exemptions or are sterile/invasive.