XO CARE A/S

XO Care A/S specializes in dental units, which are medical devices used in clinical settings for oral healthcare procedures. Their portfolio includes devices like the XO Odontosurge and XO Flex, which are designed for precision and efficiency in dental treatments. The XO Flow system appears to support functions like irrigation and suction, essential for maintaining hygiene and comfort during procedures.

XO Care A/S is headquartered in Denmark. The company’s location in Denmark aligns with EU regulatory frameworks, which may influence how its devices are developed, manufactured, and registered for use within the European market.

XO Care A/S’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and compliance with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the device’s classification and regulatory pathway.

XO Care A/S’s devices fall under Class IIa and Class IIb classifications in the EU. This classification is determined by factors like the device’s intended purpose, risk level, and potential impact on patient safety. Class IIa devices pose moderate risks, while Class IIb devices carry higher risks, requiring stricter regulatory oversight and conformity assessments before market placement.