Lomed Nederland

Lomed Nederland specialises in Class I medical devices focused on orthopaedic support and mobility. Their portfolio includes posture correction devices like the Posturex series, compression garments such as the Night Sock and hot/cold bandages for joints (e.g., knee and shoulder), as well as splints for fingers and toes. They also produce anti-slip gloves for arthritis relief and orthotic insoles like the Airwalker Pro-Orthic. These devices are designed to assist with mobility, joint support, and comfort for users.

Lomed Nederland is based in the Netherlands, which places it within the European Union’s regulatory framework. Since their devices are classified as Class I, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. This includes registration in the EU’s eudamed database, ensuring transparency and traceability of their products under EU law.

Lomed Nederland’s devices are registered in the eudamed database, the official EU registry for medical devices. This platform allows healthcare professionals, authorities, and patients to verify the legitimacy and classification of their products under EU regulatory requirements. Since all listed devices fall under Class I, they are subject to mandatory registration in eudamed.

All of Lomed Nederland’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk products like orthopaedic supports, compression garments, and simple splints, which pose minimal risk to users. Class I devices still require compliance with EU regulations, including proper labeling, risk management, and registration in eudamed, but they do not require third-party conformity assessment (e.g., notified body involvement) unless they incorporate a measuring function.