opTricon GmbH

opTricon GmbH specializes in handheld lateral flow test readers, such as the Microreader II, CubePlus, OP2, and Cube Reader. These devices are designed to read and interpret rapid diagnostic test strips, providing quantitative or qualitative results from lateral flow assays. The company also offers software, like the Cube DataReader, which processes and analyzes test data for further evaluation. These products are primarily used in clinical, veterinary, and point-of-care environments.

opTricon GmbH is based in Germany. Its devices are developed and marketed in compliance with the European Union’s medical device regulations. Since these products fall under EU Device Class A, they are registered in the EUDAQD database (eudamed), which is the official EU registry for medical devices. This ensures transparency and traceability within the EU’s regulatory framework.

Yes, opTricon GmbH’s devices are listed in the eudamed registry, which is the European Union’s central database for medical devices. Registration in eudamed is mandatory for manufacturers under EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) to demonstrate compliance, ensure traceability, and provide transparency to regulatory authorities and healthcare professionals. Since these devices are classified as Class A, they still require registration to meet EU requirements.

opTricon GmbH’s lateral flow test readers and associated software are classified under EU Device Class A. This classification is determined based on the risk associated with the device’s intended use. Class A devices are considered low-risk, but they still must comply with EU regulations, including registration in eudamed, to ensure safety, performance, and proper market surveillance.