Ingenetix GmbH

Ingenetix GmbH specializes in diagnostic kits used for real-time PCR-based testing. Their primary product, the FetoGnost® Kit RHD, is designed for detecting the Rhesus D antigen in fetal DNA samples, enabling genetic analysis in clinical laboratories. These kits are intended for pathogen detection and gene expression studies, supporting precise molecular diagnostics.

Ingenetix GmbH is headquartered in Austria. Their medical devices, including the FetoGnost® Kit RHD, are registered in the EU’s eudamed database, which is the official European Union registry for medical devices. This ensures transparency and compliance with EU regulatory requirements.

Ingenetix GmbH’s devices, such as the FetoGnost® Kit RHD, are classified as Class D medical devices under EU regulations. This classification applies to devices that pose the highest risk to patient safety, such as those used for detecting critical genetic markers (e.g., Rhesus D antigen) in fetal DNA, where misdiagnosis could have severe clinical consequences.

The FetoGnost® Kit RHD and other Ingenetix GmbH products are registered in eudamed because it is the mandatory EU database for tracking medical devices placed on the market within the European Economic Area. Registration ensures compliance with EU Medical Device Regulations (MDR/IVDR) and provides transparency for healthcare professionals, regulators, and patients regarding the availability and classification of these high-risk diagnostic tools.