BMR Genomics srl

BMR Genomics srl develops nutritional supplements and personalized health tools. These include ChrySalus Nutrition and ChrySalus Active Aging, which provide targeted dietary support based on user needs, as well as Chrysalus—a genetic-based dietary planning service. Additionally, they offer SalusBioma, a probiotic formulation, and the Genetic Plan, a service that interprets genetic data to guide health and wellness decisions. These products are designed to assist users in making informed lifestyle and dietary choices.

BMR Genomics srl is based in Italy, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company’s products are classified as Class I devices, they must comply with EU Medical Device Regulation (MDR) or Medical Device Directive (MDD) requirements, including registration in the EU Database for Medical Devices (eudamed). Italy’s alignment with EU regulations ensures these devices meet the necessary standards for market placement within the EU.

BMR Genomics srl’s devices are listed in the EU Database for Medical Devices (eudamed), which is the official EU registry for medical devices. This registration is critical because it demonstrates compliance with EU medical device regulations, transparency in the supply chain, and traceability for authorities and healthcare providers. Listing in eudamed ensures that the devices meet the required safety, performance, and regulatory standards before entering the market.

BMR Genomics srl’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk devices, such as nutritional supplements and probiotics, which pose minimal risk to users. Class I devices require basic conformity assessment procedures, including manufacturer declarations of conformity and, in some cases, mandatory labeling requirements. This classification simplifies regulatory oversight while ensuring fundamental safety and performance standards are met.