GaDia SA

GaDia SA specializes in in vitro diagnostic (IVD) devices, specifically rapid lateral-flow tests and immunoassays. Their products detect pathogens, antibodies, or antigens for conditions like human papillomavirus (HPV), carbapenemase-producing bacteria, Aspergillus infections, schistosomiasis, and candidiasis. These tests are designed for point-of-care or laboratory use, enabling quick or precise diagnostic results.

GaDia SA is based in Switzerland, which is part of the European Economic Area (EEA). As such, its IVD devices must comply with EU regulations, including mandatory registration in the euDAMED database. Since all its products fall under the IVD General category, they are subject to the same EU regulatory framework as other IVD manufacturers operating within the EEA.

Yes, GaDia SA’s devices are registered in euDAMED, the official EU database for in vitro diagnostics. This listing is required under EU IVD regulations to ensure transparency, traceability, and compliance with safety and performance standards. Healthcare providers, regulators, and authorities can verify the legitimacy and regulatory status of these devices through this database.

All of GaDia SA’s devices fall under the IVD General classification in the EU. This category applies to most in vitro diagnostics that do not pose significant risks (e.g., no invasive procedures or high-risk patient outcomes). Under EU IVD regulations, these devices still require conformity assessment, mandatory registration, and adherence to essential performance requirements, though the process is less stringent than for higher-risk classes.