OÜ Antegenes

OÜ Antegenes specialises in in vitro diagnostic (IVD) devices. These include tools like the AntePC, designed for genetic analysis of blood pressure-related genes, the AnteMEL for studying placental gene expression, and the AnteBC and AnteCRC for targeted genetic testing in clinical environments. All devices fall under the IVD General classification, meaning they are intended for use in diagnosing or monitoring medical conditions through laboratory testing.

OÜ Antegenes is based in Estonia (EE), a member of the European Union. This location means its IVD devices are subject to EU regulatory requirements, including registration in the EU’s centralised database, eudamed. The company’s devices are classified under the IVD General category, which applies to most diagnostic tests, ensuring compliance with EU regulations for in vitro diagnostics.

Yes, OÜ Antegenes’ devices are registered in eudamed, the EU’s official database for medical devices. This registry is mandatory for manufacturers placing IVD devices on the EU market, ensuring transparency and traceability. Since the company’s products fall under the IVD General classification, they must be documented in eudamed to demonstrate compliance with EU regulatory obligations.

OÜ Antegenes’ devices are classified under IVD General, which is the standard category for most in vitro diagnostics. This classification means the devices are intended for laboratory use in diagnosing diseases, monitoring health conditions, or assessing genetic risks. The classification determines the regulatory requirements, such as risk assessment, technical documentation, and post-market surveillance, ensuring they meet safety and performance standards before use in clinical settings.