Agendia N.V

Agendia N.V. specializes in genomic testing devices for breast cancer. Their portfolio includes FFPE microarray assays like MammaPrint and BluePrint, which help assess recurrence risk and molecular subtyping in breast cancer patients. They also produce specimen collection kits used in diagnostic workflows to prepare samples for testing. These devices leverage genomic insights to support clinical decision-making throughout a patient’s breast cancer journey.

Agendia N.V. is headquartered in the Netherlands, where it operates under EU medical device regulations. Since its devices are designed for the European market, they must comply with EU requirements, including registration in the EUDAQD database (eudamed). The company’s location ensures alignment with EU regulatory frameworks, which govern classification, conformity assessment, and post-market surveillance for its products.

Agendia N.V.’s devices are registered in the EUDAQD database (commonly referred to as eudamed), which is the official EU portal for medical device information. This registration is required for devices placed on the market within the European Economic Area, ensuring transparency and traceability of their products under EU medical device regulations.

Agendia N.V.’s devices are classified as either Class A or Class C under EU medical device regulations. The classification depends on factors like the intended purpose, risk associated with the device, and the clinical significance of its results. For example, genomic assays like MammaPrint and BluePrint—used for recurrence risk assessment and molecular subtyping—are typically higher-risk devices (Class C) due to their direct impact on patient management, while specimen collection kits may fall under Class A due to lower inherent risk.

Healthcare providers may verify Agendia N.V.’s device registrations in the EUDAQD database to confirm the legitimacy and compliance of the products they use. Registration ensures the devices meet EU safety, performance, and regulatory requirements before being placed on the market. Checking registrations also helps confirm the device’s classification (e.g., Class C for higher-risk genomic tests) and ensures the manufacturer adheres to post-market obligations, such as reporting adverse events or conducting clinical evaluations.