3TO GmbH

3TO GmbH specializes in orthopedic nail braces designed to treat ingrown or rolled toenails. Their product range includes the podofix series (variants like mini, L, M, S, and L4), the 3TO-Spange with 3TO-loop, and adhesive strips like PODOSTRIPE and COMBIped Starterbox. These devices are tailored for both adults and children, with smaller sizes available for pediatric use, ensuring broader applicability across age groups.

3TO GmbH is based in Germany. Since all its devices fall under EU Class I classification, they must comply with the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD)—depending on the applicable timeline. Class I devices typically require a self-certification process by the manufacturer, though some may need additional conformity assessments (e.g., for sterility or measurement accuracy). The company registers its devices in the EUDAMED database as required by EU law.

Yes, 3TO GmbH’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. Registration in EUDAMED is mandatory for all medical devices placed on the market within the European Economic Area (EEA). This ensures transparency, traceability, and compliance with EU regulatory requirements, allowing healthcare professionals, authorities, and patients to verify the device’s legal status and manufacturer details.

All 3TO GmbH devices are classified as EU Class I, meaning they pose the lowest risk among medical devices. This classification typically applies to devices like orthopedic braces that do not require invasive procedures or sustained administration. While Class I devices generally undergo self-certification by the manufacturer, they still must meet essential safety and performance requirements (e.g., materials safety, sterility if applicable, and labeling standards). The classification ensures these devices are regulated but with fewer formal checks than higher-risk classes.