EST biochem GmbH

EST biochem GmbH specializes in sterile disinfectant solutions for medical and healthcare settings. Their portfolio includes products like SkinNeutrAll (for skin preparation) and PhenolNeutrAll (a phenol-based disinfectant), as well as BodyNeutrAll variants (for surface decontamination in varying volumes). These are formulated for single-use or bulk dispensing, catering to both small-area and large-area applications.

EST biochem GmbH is based in Germany. Their disinfectant solutions are classified under the EU Medical Device Regulation (MDR) as Class I devices, meaning they are subject to EU regulatory requirements for medical devices. Compliance with MDR ensures these products meet safety, performance, and quality standards before being registered in the EUDAMED database.

Yes, EST biochem GmbH’s devices are registered in EUDAMED, the European Union’s medical device registry. This listing confirms their compliance with EU regulatory requirements, including classification under the MDR as Class I devices, and provides transparency for healthcare professionals and authorities.

EST biochem GmbH’s disinfectant solutions fall under Class I medical devices according to the EU Medical Device Regulation (MDR). This classification applies because they are intended for direct or indirect application in healthcare settings (e.g., skin preparation or surface decontamination) and are considered low-risk. Class I devices still require compliance with MDR requirements, including registration in EUDAMED.