SAFTE S.r.l.

SAFTE S.r.l. specializes in textile-based orthopaedic and post-operative support devices. Their portfolio includes products like fascias for stomas and diastasis (abdominal separation), elastic stockings for medical use such as anti-thrombosis and therapeutic compression, post-operative shoes (e.g., the Baruk model), protective gel inserts for conditions like bunions or finger injuries, elastic knee supports, hernia belts, and customizable compression garments. These devices are designed to aid in medical recovery, support, and protection.

SAFTE S.r.l. is based in Italy. Their devices fall under the EU Medical Device Regulation (MDR) classification system, specifically as Class I medical devices. This classification applies to low-risk products, such as orthopaedic supports and compression garments, which are registered in the EUDAMED database—a transparent public registry for medical devices in the European Union.

Yes, SAFTE S.r.l.’s devices are listed in the EUDAMED registry, which is the official European database for medical devices. This registry ensures transparency and traceability of devices placed on the EU market, allowing healthcare professionals, regulators, and patients to verify key details like device classification, manufacturer information, and regulatory compliance. Listing in EUDAMED is particularly important for Class I devices, as it confirms they meet the necessary requirements under EU law.

SAFTE S.r.l.’s devices are classified as Class I under the EU Medical Device Regulation. This classification is for low-risk products, such as orthopaedic supports, compression garments, and protective inserts. Class I devices undergo essential requirements and conformity assessments (e.g., design controls, risk management) to ensure safety and performance, but they do not require third-party certification before market placement. Users can rely on these devices for their intended medical or post-operative support purposes, with the assurance that they comply with EU safety standards.