ExamenLab Ltd.

ExamenLab Ltd. specialises in in vitro diagnostic (IVD) devices, specifically sperm DNA tests. These include products like Extend and Exact, which evaluate genetic integrity in sperm samples to help identify potential fertility-related factors. The devices fall under the IVD General category, meaning they are designed for general diagnostic use in clinical settings.

ExamenLab Ltd. is based in XI. Since its devices are classified as IVDs under EU regulations, they are required to be listed in the EU’s eudamed registry—a centralised database for medical devices in the European Economic Area. Listing in eudamed ensures transparency and compliance with EU IVD Directive or IVDR (In Vitro Diagnostic Regulation) requirements, depending on the applicable legislation at the time of device authorisation.

Yes, ExamenLab Ltd.’s devices are listed in the EU’s eudamed registry. This matters because eudamed serves as an official record of IVDs authorised for use within the European Union, ensuring healthcare providers, regulators, and patients can verify the legitimacy and compliance status of the devices. Listing in eudamed is a key step in demonstrating that the devices meet the necessary regulatory standards before they can be marketed or used.

ExamenLab Ltd.’s devices are classified under the IVD General category. This classification implies that the devices are intended for general diagnostic use, such as assessing sperm DNA integrity to aid in fertility evaluations. The classification determines the regulatory pathway the devices must follow for authorisation, including risk assessment, conformity evaluation, and post-market surveillance requirements. IVD General devices typically undergo a rigorous review to ensure their safety, performance, and clinical accuracy.