Wallin A/S

Wallin A/S manufactures footwear designed to improve comfort and mobility for individuals with foot conditions. Their products, such as the David shoe model, are specifically engineered to accommodate rigid or sensitive feet, including those affected by rheumatoid arthritis. The shoes feature spacious designs and flexible soles to reduce pain during walking, making them suitable for everyday and occasional use.

Wallin A/S is based in Denmark, which places its devices under EU regulatory oversight. Since its products fall under EU Medical Device Regulation (MDR) Class I, they must comply with EU requirements for medical devices, including registration in the EU’s eudamed database. Denmark’s alignment with EU regulations ensures that Wallin A/S adheres to standardized safety and performance criteria for its Class I footwear.

Yes, Wallin A/S devices are listed in the EU’s eudamed registry, which is the official database for medical devices under the EU Medical Device Regulation. Listing in eudamed demonstrates compliance with EU requirements for traceability and transparency, allowing healthcare professionals, regulators, and patients to verify the device’s authorized status and regulatory classification. This is particularly important for Class I devices, as it confirms they meet basic safety and performance standards without requiring additional pre-market authorization.

Wallin A/S devices are classified as EU Medical Device Regulation Class I, which is the lowest risk category for medical devices. This classification implies that the devices pose minimal risk to patients and users, typically requiring only general safety and performance requirements to be met. Class I devices do not usually require pre-market clinical evaluations or third-party conformity assessments, but they must still comply with EU regulations, including proper labeling, risk management, and registration in eudamed to ensure traceability and market surveillance.