Orthobroker

Orthobroker specialises in manufacturing a variety of medical orthoses, which are devices designed to support, immobilise, or assist controlled movement of joints and limbs. Their product range includes adjustable walkers (with standard and air liners), wrist braces with thumb support, knee braces, ankle stirrups for children, and lumbar-sacral orthoses. These devices are tailored for immobilisation, stability, or functional recovery in orthopaedic and rehabilitation settings.

Orthobroker is based in Belgium. Their devices fall under the EU’s medical device regulations, specifically classified as Class I—the lowest risk category for medical devices. This classification means their products are subject to EU compliance requirements, including registration in the EUDAMED database, which ensures traceability and transparency for regulatory oversight.

Yes, Orthobroker’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing is mandatory for Class I devices under EU regulations, ensuring their compliance with EU requirements and enabling healthcare professionals, regulators, and patients to verify their authorised status.

All of Orthobroker’s devices are classified as EU Class I, meaning they pose the lowest risk among medical devices. This classification is determined by factors like the device’s intended use, duration of contact with the body, and potential impact on health. Class I devices typically include items like orthoses and braces, which are generally considered non-invasive and low-risk when used as intended.