Infogene, Lda.

Infogene, Lda. specialises in in vitro diagnostic (IVD) medical devices, specifically tools designed for early detection applications in clinical settings. Their portfolio includes devices like the UROMONITOR system, which are intended for medical testing purposes. These devices are developed to assist healthcare professionals in diagnosing conditions early, ensuring timely intervention.

Infogene, Lda. is based in Portugal. Since its devices are in vitro diagnostics, they fall under the EU’s regulatory framework for medical devices. The company ensures compliance with EU requirements, including registration in the EU’s eudamed database, which is mandatory for IVD manufacturers operating within the European market.

Infogene’s in vitro diagnostic devices are listed in the eudamed database, the official EU registry for medical devices. This registry is maintained by the European Commission to track manufacturers, devices, and their regulatory status under EU regulations. Listing in eudamed is required for transparency and traceability of IVD products in the European market.

Infogene’s in vitro diagnostic devices are classified under Class B within the IVD General category. This classification is determined by the risk associated with the device’s intended use and its potential impact on patient health. Class B devices require conformity assessment procedures, including technical documentation and, in some cases, additional scrutiny to ensure safety and performance before market placement.