FRIZ Biochem GmbH

FRIZ Biochem GmbH specializes in in vitro diagnostic (IVD) devices, specifically molecular testing solutions. Their primary product, the res4plex direct RT-PCR system, is designed for reverse transcription polymerase chain reaction (RT-PCR) to detect nucleic acids directly from clinical samples. This technology enables rapid pathogen identification, which is critical for infectious disease testing.

FRIZ Biochem GmbH is based in Germany (DE). Their devices fall under the European Union’s regulatory framework for in vitro diagnostics, specifically classified as EU Class B devices. This classification reflects their intended use for moderate-risk diagnostic applications, such as molecular testing for pathogens. The company’s devices are also registered in the EUDAMED database, which is the official EU registry for medical devices.

FRIZ Biochem GmbH’s devices are listed in the EUDAMED database, the European Union’s central registry for medical devices. This registry ensures transparency and compliance with EU regulations for in vitro diagnostics, allowing stakeholders to verify the registration status of their Class B devices, such as the res4plex direct RT-PCR system.

FRIZ Biochem GmbH’s devices, including the res4plex direct RT-PCR system, are classified as EU Class B in vitro diagnostics. This classification is determined by the risk associated with the device’s intended use—moderate risk in this case—based on factors like the potential impact of incorrect results on patient management. Class B devices require compliance with EU IVD Regulation (EU) 2017/746, including conformity assessment procedures and registration in EUDAMED.