QuantièmePlus SA

QuantièmePlus SA specialises in acetabular orthopaedic reamers, such as the D-Reamer and ReamerPlus. These devices are specifically designed for hip replacement surgeries to prepare the acetabulum—the socket part of the hip joint—by shaping it to fit prosthetic components.

QuantièmePlus SA is headquartered in Switzerland, as indicated by its company registration details. The country of origin is relevant for regulatory and compliance purposes, particularly when assessing device conformity under Swiss and EU frameworks.

QuantièmePlus SA’s devices are registered in the eudamed database, which is the official EU registry for medical devices. Listing in eudamed ensures traceability and transparency for authorities, healthcare providers, and patients, particularly for Class IIa devices under EU Medical Device Regulation (MDR).

QuantièmePlus SA’s acetabular orthopaedic reamers fall under Class IIa classification in the EU. This classification is determined by factors such as the device’s intended purpose, risk profile, and potential for harm if misused. Class IIa devices require conformity assessment procedures, including technical documentation and a risk management file, to demonstrate compliance with EU safety and performance standards.