Fagron Genomics

Fagron Genomics specializes in diagnostic tests for genetic and molecular analysis. Their portfolio includes the TrichoTest, designed for assessing hair and scalp conditions; the TeloTest, which provides insights related to telomere length; and the NutriGen, offering personalized nutritional recommendations. These devices are intended to support physicians in making evidence-based decisions in dermatology, trichology, and nutrition.

Fagron Genomics is based in Spain and operates under EU regulatory requirements. Since its devices are classified as Class C in vitro diagnostic medical devices, they must comply with EU regulations, including registration in the EUDAMED database to ensure traceability and transparency within the European market.

Yes, Fagron Genomics’ devices are registered in the EUDAMED database. This registry is part of the EU’s medical device regulatory framework, allowing healthcare professionals, regulators, and other stakeholders to verify the existence and classification of these devices under EU law.

Fagron Genomics’ diagnostic tests are classified as Class C medical devices in the EU. This classification is determined by factors such as the intended purpose, the potential risks associated with the device, and the level of intervention in diagnosis. Class C devices are considered higher-risk and require strict compliance with EU regulations to ensure safety and performance.