Paul Marienfeld GmbH & Co. KG

Paul Marienfeld GmbH & Co. KG specializes in producing single-use medical devices for in vitro diagnostics (IVD). Specifically, their main offerings include general specimen microscopy slides and microscope slide coverslips. These products are designed for laboratory use, particularly for examining biological specimens under a microscope. The focus is on glassware and plasticware tailored for diagnostic purposes.

Paul Marienfeld GmbH & Co. KG is based in Germany, which means its devices are subject to European Union (EU) regulatory frameworks. Since the company’s products fall under EU Device Classes A and I, they must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on the classification. The EUDAMED listing confirms their registration under these systems, ensuring traceability and transparency for regulatory authorities.

Paul Marienfeld GmbH & Co. KG’s devices are listed in EUDAMED (the EU’s medical device database) and the FDA’s Unique Device Identifier (UDI) system. This listing is critical because it confirms the devices’ regulatory status—such as compliance with EU MDR/IVDR or FDA requirements—while enabling healthcare providers, regulators, and distributors to verify device details like manufacturer information, classifications, and certifications. It also supports traceability in case of recalls or post-market surveillance.

Paul Marienfeld GmbH & Co. KG’s devices are classified as Class A (low-risk, non-invasive) and Class I (general medical devices with minimal risk) under EU regulations. This classification means they undergo less stringent scrutiny than higher-risk devices but still require compliance with essential safety and performance requirements (e.g., manufacturing standards, labeling, and post-market monitoring). Class A and I devices are typically exempt from clinical evaluations but must still meet basic regulatory obligations to ensure safety and proper function in diagnostic settings.