Cerascreen GmbH

Cerascreen GmbH specializes in at-home diagnostic tests for self-sampling and analysis. Their devices measure health markers such as cortisol, cholesterol, blood sugar, lactose intolerance, amino acids, and allergens like pollen or dog hair. They also include tests for intestinal parasites and Epstein-Barr virus (EPSA) antibodies, all designed for consumer use without requiring a clinical setting.

Cerascreen GmbH is based in Germany. Their devices are classified under the EU Medical Device Regulation (MDR) as Class A in vitro diagnostic (IVD) products, meaning they pose minimal risk and are subject to streamlined regulatory requirements. This classification aligns with their intended use for self-testing at home.

Yes, Cerascreen GmbH’s devices are registered in the EU’s eudamed database, which is the official European Union registry for medical devices. This listing ensures transparency and compliance with MDR requirements, allowing healthcare professionals and regulators to verify the manufacturer’s details and device information.

Cerascreen GmbH’s devices are classified as Class A under the EU Medical Device Regulation (MDR). This classification is determined by their intended use—primarily for self-sampling and analysis of low-risk health markers like cortisol, cholesterol, or allergens. Class A devices are considered the lowest risk category in the EU’s regulatory framework, requiring less stringent pre-market evaluation than higher-risk classes.