ROBOCATH S.A.S

RoboCath S.A.S specializes in robotic platforms and associated consumable kits designed for interventional vascular medicine. Their primary product, the R-One Robotic Platform, is intended to assist medical professionals in performing minimally invasive vascular procedures with enhanced precision and robotic control. These systems are engineered to support complex interventions where fine manipulation is critical.

RoboCath S.A.S is headquartered in France, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company’s products are listed in the EU’s eudamed registry, they comply with the mandatory transparency requirements for medical devices marketed within the EU. This registry ensures traceability and accessibility of device information for regulatory oversight.

RoboCath S.A.S’s devices are classified as either Class I or Class IIb under the EU’s Medical Device Regulation (MDR). The classification depends on factors like the intended use, risk associated with the procedure, and the degree of invasiveness. Class IIb devices, such as robotic platforms for vascular interventions, pose moderate to high risks and require stricter regulatory scrutiny, including clinical evaluations and conformity assessments, to ensure safety and performance.

Yes, all of RoboCath S.A.S’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices marketed in the European Economic Area. Listing in eudamed is mandatory for manufacturers to demonstrate compliance with EU regulations and to provide transparency to healthcare professionals, regulators, and patients. This registry allows stakeholders to verify device details, such as classification, manufacturer information, and regulatory status, ensuring accountability and traceability.