ORTHOMEDICA

Orthomédica specializes in Class I orthopedic support devices designed for temporary use. These include lumbar belts (such as the L4L5S1 PRO and classic versions in multiple sizes), cervical collars (e.g., C1 marine and adjustable models), knee immobilizers (universal sizes S, M, L, and XL), wrist/ankle straps, forearm supports, thumb orthoses, and wheelchair seatbelt systems like the SMF100. The devices focus on immobilization, posture correction, or post-injury stabilization of joints and spinal regions.

Orthomédica is based in France and operates under EU medical device regulations. Since its devices fall under Class I—defined as low-risk, non-invasive orthopedic supports—they must comply with EUDAMED registration requirements. This classification means they undergo minimal regulatory scrutiny compared to higher-risk devices but still require adherence to EU safety and performance standards.

Yes, Orthomédica’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms their compliance with EU medical device regulations, including mandatory requirements for Class I products such as manufacturer details, device descriptions, and regulatory status. EUDAMED serves as a transparent resource for stakeholders to verify authorized devices.

Orthomédica’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk products like orthopedic supports, which are intended for temporary use (e.g., posture correction, immobilization, or post-injury stabilization). Class I devices require basic compliance measures, such as manufacturer declarations of conformity and EUDAMED registration, but do not need third-party certification unless they incorporate measuring functions or are reusable.