Laboratoires Majorelle

Laboratoires Majorelle specializes in medical devices primarily focused on women’s health and urology. Their portfolio includes the Keat product line, which is designed for preventive, protective, and supportive clinical applications in these areas. The devices are intended to assist healthcare professionals in managing patient care within these specific medical fields.

Laboratoires Majorelle is based in France. Since their devices fall under the scope of the European Union’s Medical Device Regulation (MDR), they are subject to EU regulatory requirements, including mandatory registration in the EU’s eudamed database.

Laboratoires Majorelle’s devices are listed in the EU’s official medical device registry, eudamed. This database is maintained under the EU Medical Device Regulation (MDR) to ensure transparency and traceability of medical devices authorized for use within the European market.

Laboratoires Majorelle’s devices are classified as Class IIa under the EU Medical Device Regulation (MDR). This classification is determined based on the risk associated with the device’s intended use and design, with Class IIa representing a moderate risk level requiring additional scrutiny and conformity assessment procedures before authorization.