STERIS ITALY SRL

Steris Italy S.r.l. produces both single-use and reusable medical devices primarily focused on sterile processing and endoscopy. Their portfolio includes automated peracetic acid (PAA) sterilization systems, such as the Prolystica Auto PAA, as well as disposable accessories like the RAPIDAER Hookup and various Adaspor/Isapor solutions designed for cleaning, disinfection, and single/multi-dose applications. These devices are engineered to support sterile processing departments, operating rooms, and endoscopy suites.

Steris Italy S.r.l. is headquartered in Italy. While the company’s devices are designed for global use, its primary market focus aligns with European regulations, as evidenced by its devices being listed in the EU’s eudamed database. The company’s offerings cater to sterile processing, operating rooms, and endoscopy environments, suggesting a broad applicability across healthcare facilities in Europe and beyond.

Steris Italy S.r.l.’s medical devices are registered in the eudamed database, which is the official EU registry for medical devices. This inclusion confirms compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, ensuring traceability and transparency for authorized devices within the European market.

Steris Italy S.r.l.’s devices fall into Class I and Class IIb classifications under EU medical device regulations. Class I devices are generally low-risk, such as single-use accessories, while Class IIb devices—like certain automated sterilization systems—pose higher risks and require stricter conformity assessments. The classification determines the regulatory pathway and documentation required for authorization.