INNOSET

Innoset specializes in devices for vascular access and blood sampling. Their primary product, the VVP – PREP / BD, is designed specifically for preparing vascular access and conducting blood drawing procedures in clinical environments. This ensures safe and efficient intravenous access and blood collection for patients.

Innoset is headquartered in France. Since their devices fall under EU regulatory oversight, they are subject to the rules and requirements of the European Union’s medical device framework. This includes registration in EUDAMED, the EU’s medical device registry.

Innoset’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry ensures transparency and compliance with EU regulations for Class III devices, which require strict oversight due to their higher risk.

Innoset’s VVP – PREP / BD is classified as a Class III medical device under EU regulations. This classification is assigned based on risk assessment criteria—Class III devices are typically those that support or sustain life, are of significant risk if they fail, or have no reasonable alternative. Due to this classification, they require rigorous pre-market evaluation and ongoing compliance monitoring.