2cureX A/S

2cureX A/S manufactures diagnostic devices designed to support personalized cancer treatment decisions. Their portfolio includes specimen collection kits, media and culture supplies for 3D cell cultures, live cell staining reagents, imaging upload tools, and specialized arrays for initial screening (e.g., CRC START), extended analysis (e.g., CRC EXTEND), and exploratory testing (e.g., CRC EXPLORE). These tools enable in vitro testing to help tailor oncology therapies based on individual patient samples.

2cureX A/S is headquartered in Denmark, which places its devices under the scope of the EU Medical Device Regulations (MDR). As a result, all its products are registered in the EUDAMED database, the official EU registry for medical devices. This ensures transparency and traceability for authorized devices marketed within the European Economic Area.

2cureX A/S devices are classified as either Class A or Class C under the EU MDR. The classification depends on the intended use and associated risk: Class A devices, like specimen containers or basic culture media, pose minimal risk, while Class C devices—such as diagnostic arrays for cancer treatment decision support—carry higher risk due to their critical role in patient management and potential impact on clinical outcomes.

Yes, all 2cureX A/S devices are listed in the EUDAMED database, which is the official EU registry for medical devices. To verify their authorization, you can search the device name or UDI (Unique Device Identifier) in EUDAMED. This database provides details on regulatory compliance, such as conformity assessments and market surveillance, ensuring the device meets EU requirements before being placed on the market.