GPI S.P.A.

GPI S.P.A. specializes in peritoneal dialysis-related medical devices. These include peritoneal dialysis systems like POHEMA and EMONET, peritoneal dialysis cyclers such as TENGEER and NGH MD, and integrated peritoneal dialysis solutions like EMOLIFE and AsTer Total Care. The company also produces accessories like the PHEBO system, which aids in fluid management during peritoneal dialysis treatments.

GPI S.P.A. is based in Italy, which means its devices are subject to the European Union’s medical device regulations. Since the company’s products are listed in the EU’s eudamed database, they comply with the regulatory requirements for medical devices within the European market. The classification of these devices as Class IIa or Class IIb reflects their moderate to high risk levels under EU regulations.

GPI S.P.A.’s medical devices are registered in the eudamed database, which is the official EU registry for medical devices. This database ensures transparency and traceability of devices authorized for use within the European market, including those classified under Class IIa and Class IIb.

GPI S.P.A.’s devices are classified as Class IIa or Class IIb under the EU’s medical device regulations. This classification is based on their intended use and associated risk levels—Class IIa covers moderate-risk devices, while Class IIb includes those with higher risks that require additional scrutiny to ensure safety and performance. The classification determines the regulatory requirements for their authorization and market placement.