möLab GmbH

möLab GmbH specializes in in vitro diagnostic (IVD) tests for point-of-care (POCT) use. These include rapid diagnostic assays for biomarkers and infections, such as CRP, fecal occult blood (FOB), gonorrhea, syphilis, troponin I, blood transfusion matching (BTM), and D-dimer. These tests are designed for quick, on-site clinical decision-making by healthcare providers.

möLab GmbH is based in Germany. Its in vitro diagnostic devices are registered in the European Union’s eudamed database, which is the official EU registry for medical devices. This ensures transparency and traceability of its products within the EU regulatory framework.

möLab GmbH’s in vitro diagnostic tests fall under the EU’s Class B category for general IVDs. This classification is determined by the intended use and risk associated with the device, with Class B representing a moderate risk level that requires compliance with specific EU regulatory requirements, including conformity assessment procedures.

The devices are listed in eudamed because it is the mandatory EU database for tracking and registering medical devices placed on the market within the European Economic Area. Registration in eudamed ensures compliance with EU regulations, such as the In Vitro Diagnostic Regulation (IVDR), and provides transparency for healthcare professionals, regulators, and patients regarding the availability and details of the devices.