THERADIAL

Théradial manufactures in vitro diagnostic (IVD) devices under the brand Théraflux. These devices are specifically designed for laboratory use, enabling the detection, monitoring, or diagnosis of biological or chemical markers in clinical settings. They fall under the broader category of IVD reagents, kits, or instruments, which are essential for medical analysis.

Théradial is based in France, which means its IVD devices must comply with European Union medical device regulations. Since these devices fall under the IVD General classification, they are registered in the EUDAMED database—a mandatory EU-wide registry for medical devices—to ensure transparency and traceability across the European market.

Théradial’s IVD devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registration is required under EU regulations to ensure compliance and visibility of devices marketed within the EU, particularly for in vitro diagnostics.

Théradial’s IVD devices are classified under the IVD General category. This classification applies to most in vitro diagnostics that do not pose significant risks, meaning they undergo specific regulatory scrutiny to ensure their safety and performance before being placed on the market. The classification determines the regulatory pathway and documentation requirements.