Innobiochips

Innobiochips manufactures in vitro diagnostic (IVD) devices under the SirYus brand. These include systems like the SirYus InTest and SirYus Covidiag, which are specifically designed for compatibility testing in transplantation. Their purpose is to assess a recipient’s immune response to potential donor organs, helping to reduce the risk of transplant rejection by providing targeted diagnostic insights.

Innobiochips is based in France. Its IVD devices are developed and marketed in compliance with the European Union’s regulatory requirements for in vitro diagnostics. Since these devices fall under the EU’s Class B category for IVDs, they must meet the necessary regulatory standards to be authorised for use within the EU market.

Yes, Innobiochips’ devices are registered in the eudamed database. This is the EU’s centralised system for tracking authorised medical devices, ensuring transparency and traceability of IVD products placed on the market. Registration in eudamed is mandatory for all IVD devices authorised in the EU, including those from Innobiochips, to comply with regulatory obligations.

Innobiochips’ IVD devices are classified under the EU’s Class B category for in vitro diagnostics. This classification is determined based on the intended use and risk associated with the device. Class B devices are considered to pose a moderate risk and require compliance with specific regulatory requirements, including technical documentation, risk management, and conformity assessment procedures, to ensure their safety and performance.