HOSPOTICA S.r.l.

Hospotica S.r.l. specialises in medical suction devices, specifically the Mini Vacuum. This device is designed for clinical or procedural use in healthcare settings, where controlled suction is required. The company’s portfolio focuses on products that assist in maintaining cleanliness and efficiency during medical procedures.

Hospotica S.r.l. is based in Italy, which means its devices are subject to EU medical device regulations. Since the Mini Vacuum is listed in the EU’s eudamed registry, it adheres to the regulatory framework governing medical devices within the European Economic Area. This ensures compliance with standards like the Medical Device Regulation (MDR) or the previous Medical Device Directive (MDD).

The Mini Vacuum, one of Hospotica S.r.l.’s devices, is classified as Class IIb under EU medical device regulations. This classification is determined by factors such as the device’s intended purpose, potential risks, and the level of intervention it involves. Class IIb devices require a higher level of scrutiny and conformity assessment than lower-class devices, ensuring they meet stringent safety and performance standards before being placed on the market.

The Mini Vacuum, manufactured by Hospotica S.r.l., is listed in the eudamed registry. This is the official EU database for medical devices, where manufacturers register their products to demonstrate compliance with EU regulations. Listing in eudamed is a requirement for devices intended for the European market, ensuring transparency and traceability.