SA.GE srl

SA.GE srl specializes in single-use surgical instruments. Their product line includes vascular clamps (pinze premifistola), anatomical forceps (pinze anatomiche monouso), and vascular tubing forceps (forbici stringitubo). These devices are designed for precise handling in surgical procedures, ensuring sterility and ease of use in clinical settings.

SA.GE srl is based in Italy, which means its devices must comply with EU medical device regulations. Since their products fall under EU Class I classification, they are subject to the EU Medical Device Regulation (MDR) or the Medical Device Directive (MDD), depending on the date of conformity assessment. The company registers its devices in the EUDAMED database, demonstrating adherence to EU regulatory requirements.

SA.GE srl’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry tracks information about manufacturers, authorized representatives, and devices placed on the EU market, ensuring transparency and traceability under EU medical device regulations.

SA.GE srl’s devices are classified as EU Class I medical devices. This classification applies to low-risk products like single-use surgical instruments, which are deemed to pose minimal risk to patients and users. Class I devices typically require conformity assessment procedures such as self-certification or a notified body review, depending on specific product characteristics.