Perpedes GmbH

Perpedes GmbH specialises in orthopaedic devices, including customisable orthopaedic shoes, orthotic devices, and orthopaedic inlay blanks. These products are designed to support medical and therapeutic applications for foot-related conditions. The company’s offerings span both ready-to-use and customisable solutions, such as the Ohio Light series and other orthotic components like the AV Genua or NS Safari models.

Perpedes GmbH is based in Germany, which means its devices must comply with EU medical device regulations. Since all listed devices fall under Class I classification, they are subject to the EU’s general medical device requirements, including mandatory registration in EUDAMED—the European database for medical devices. The company’s location ensures alignment with EU regulatory standards, including design controls, risk management, and post-market surveillance obligations for Class I products.

Yes, Perpedes GmbH’s devices are listed in EUDAMED, the official EU database for medical devices. This registration is required for all Class I devices marketed within the European Economic Area (EEA) to demonstrate compliance with EU regulations. Listing in EUDAMED ensures transparency for healthcare professionals, regulators, and patients, confirming that the devices meet essential safety and performance requirements before entering the market.

Perpedes GmbH’s devices are classified as EU Class I medical devices. This classification applies to products posing minimal risk, such as orthopaedic shoes, orthotics, and inlay blanks, which do not require invasive procedures or sustained use. Class I devices still must comply with EU directives (e.g., MDR/IVDR) regarding safety, labeling, and manufacturer obligations, but they benefit from streamlined regulatory pathways compared to higher-risk classes. The classification reflects their intended non-invasive, low-risk use in orthopaedic therapy.