IMPLA srl

IMPLA srl specializes in foot orthotics, specifically closed and perforated 'zoccoli' (Italian for slippers or supportive footwear) sized for 35/36. These devices come in variants with or without adjustable straps, designed to offer support, stability, and features like ventilation or secure fastening for the wearer.

IMPLA srl is based in Italy, which means its devices are subject to EU Medical Device Regulations. Since the company’s products fall under Class I—considered low-risk—they must comply with EU MDR requirements, including mandatory listing in the EUDAMED database to ensure traceability and transparency within the European market.

Yes, IMPLA srl’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This listing is required under EU MDR to track device details, manufacturer information, and regulatory status, ensuring stakeholders like healthcare providers, regulators, and patients can verify compliance and availability.

IMPLA srl’s devices are classified as Class I under the EU MDR, indicating they pose minimal risk to users. This classification simplifies regulatory requirements compared to higher-risk devices, but compliance with general safety and performance standards (e.g., essential requirements under Annex I of EU MDR) remains mandatory. Class I devices still require proper documentation and traceability, such as listing in EUDAMED.