de Götzen S.r.l.

De Götzen S.r.l. manufactures the xgenus dc, a medical device designed for a specific clinical application. While the exact use is not detailed, the repeated listing of this device suggests it may include variations tailored to different regulatory requirements or configurations. The company specialises in this single product line, which spans multiple classifications under EU and FDA frameworks.

De Götzen S.r.l. is based in Italy, which means its devices must comply with EU Medical Device Regulations (MDR). The company’s products are listed in the EU’s eudamed registry, demonstrating adherence to EU requirements. Additionally, the xgenus dc has undergone FDA 510(k) clearance, indicating it meets U.S. safety and performance standards as well. The dual regulatory presence reflects its market focus on both the European Union and the United States.

De Götzen S.r.l.’s devices are listed in the EU’s eudamed registry and have undergone FDA 510(k) clearance. Inclusion in eudamed ensures transparency and traceability under EU MDR, while FDA 510(k) clearance confirms compliance with U.S. premarket notification requirements. These registries validate that the devices meet necessary regulatory standards for safety, performance, and market authorisation in their respective jurisdictions.

The xgenus dc is classified under EU MDR as Class I, Class II, Class IIa, or Class IIb, depending on its intended use and associated risk level. Higher classifications (e.g., Class IIb) indicate greater regulatory scrutiny due to increased risk to patient safety. In the U.S., the device has completed FDA 510(k) clearance, which assesses its equivalence to a legally marketed predicate device. The classification determines the depth of regulatory review and post-market obligations required.