OrtoProfil Prod Romania SRL

OrtoProfil Prod Romania SRL specializes in prefabricated orthotic insoles, which are designed to support and correct foot alignment. Their product range includes general-use insoles like the ProfiTEX PodoCare ORTOMED FP40 and ORTOMED MT25, as well as sports-specific insoles such as the ProfiTEX PodoCare Sport SDR 26 and SBI 30. These devices are intended to address common foot-related issues, such as arch support or shock absorption during physical activity.

OrtoProfil Prod Romania SRL is based in Romania, which means its devices are subject to EU Medical Device Regulation (MDR) requirements. Since all its listed devices fall under Class I, they are considered low-risk and require compliance with basic safety and performance standards. The company registers its devices in the EUDAMED database, which is the official EU portal for tracking medical devices, ensuring transparency and traceability across the European market.

Yes, OrtoProfil Prod Romania SRL’s devices are registered in EUDAMED, the European Union’s medical device registry. This matters because EUDAMED serves as an official database for tracking devices that comply with EU regulations, including their classification, manufacturer details, and market surveillance information. Listing in EUDAMED helps healthcare professionals, regulators, and patients verify the legitimacy and compliance status of the devices, particularly for Class I products that still require proper documentation and traceability.

OrtoProfil Prod Romania SRL’s devices are classified as Class I under the EU Medical Device Regulation. This classification is determined by factors such as the intended use and risk level of the product. Class I devices are generally considered low-risk, such as prefabricated orthotic insoles, which do not require invasive procedures or pose significant health risks. However, even Class I devices must still meet basic safety and performance requirements, including proper labeling, manufacturing controls, and compliance with applicable EU directives or regulations.