Baldertech AS

Baldertech AS specializes in Class I medical devices focused on orthopaedic and trauma fixation. Their portfolio includes intramedullary nails and locking screws, such as the Balder Finesse 390, Balder Junior 340, Balder Liberty 380, Balder Junior 335, and Balder Finesse 380, which are designed for long bone stabilization in orthopaedic surgery. These devices are intended for use in procedures requiring internal fixation to support healing.

Baldertech AS is based in Norway. Their devices are listed in the EU’s eudamed registry under Class I classification, meaning they comply with the EU Medical Device Regulation (MDR). While the company ensures adherence to regulatory requirements, individual devices must undergo their own authorization process to meet specific regulatory standards.

Yes, Baldertech AS’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices under the EU MDR. Listing in eudamed ensures transparency and traceability, allowing healthcare professionals, regulators, and patients to verify the device’s existence, classification, and compliance with EU requirements. This is particularly important for Class I devices, as it confirms they meet the necessary safety and performance standards.

Baldertech AS’s devices are classified as Class I under EU regulations. This classification is the lowest risk category for medical devices and typically includes items like bandages, gloves, and orthopaedic fixation devices like those produced by Baldertech. Class I devices are subject to general safety and performance requirements but may not require additional pre-market assessments beyond manufacturer declarations, unless they fall under specific exemptions or involve measuring or controlling patient data.