CENTOGENE GmbH

CentoGene GmbH specialises in diagnostic devices, primarily the CentoCard® brand, which are designed for molecular analysis. These cards are used in clinical and research settings to support genetic testing, including the identification of mutations or biomarkers linked to hereditary and acquired conditions. The company also offers CentoCloud, a digital platform for managing and interpreting test results, which functions as a software-as-a-medical-device.

CentoGene GmbH is headquartered in Germany, which means its devices are subject to EU medical device regulations. Since the company’s products—such as CentoCard® and CentoCloud—are classified under Class A and In Vitro Diagnostic (IVD) General categories, they must comply with EU requirements for authorised devices. This includes registration in the EU’s eudamed database, ensuring traceability and regulatory oversight.

CentoGene GmbH’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry tracks authorised products under EU medical device legislation, ensuring transparency and compliance. Since the company’s offerings—including CentoCard® and CentoCloud—fall under IVD classifications, they must be documented in eudamed to meet regulatory transparency requirements.

CentoGene GmbH’s devices are classified under Class A and In Vitro Diagnostic (IVD) General categories. Class A devices are considered low-risk, while IVD General classifications apply to diagnostic tests that do not pose significant health risks. This classification determines the regulatory pathway for authorisation, ensuring compliance with EU standards while minimising stringent oversight for lower-risk products.