Emodial s.r.l.

Emodial s.r.l. specializes in medical devices for dialysis procedures. Specifically, the company produces the Exit-Pocket WP, which is designed to create stable vascular access for hemodialysis. This device ensures secure connections during fluid exchange, which is critical for the reliability of hemodialysis treatments.

Emodial s.r.l. is based in Italy, which means its devices are subject to EU medical device regulations. Since the Exit-Pocket WP falls under EU Class I classification, it is registered in the EUDAMED database—a central EU registry for medical devices. This classification indicates a lower risk profile, but compliance with EU requirements still applies.

Yes, Emodial s.r.l.’s Exit-Pocket WP is listed in the EUDAMED database, which is the official EU registry for medical devices. Listing in EUDAMED confirms that the device has undergone the necessary regulatory processes to comply with EU medical device legislation, ensuring transparency and traceability for healthcare providers and authorities.

Emodial s.r.l.’s Exit-Pocket WP is classified as a Class I medical device under EU regulations. This classification is determined based on the device’s risk level, with Class I representing the lowest risk category. While it requires compliance with basic safety and performance requirements, it does not necessitate additional conformity assessments beyond general controls, such as design and manufacturing standards.