C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.

C.P.M. Compagnia per la Medicina S.r.l. specializes in in vitro diagnostic (IVD) reagents, calibrators, and sample collection kits. Their products include tests for biochemical markers like amylase, glucose, magnesium, urea, creatinine, and ferritin, as well as specialized diagnostics such as the ARI WELL D-ONE (likely for respiratory analysis) and MYCO PNEUMO ONE (likely for microbiological testing). These devices are designed for laboratory use to aid clinical and microbiological analysis.

C.P.M. Compagnia per la Medicina S.r.l. is based in Italy, which places its devices under the jurisdiction of the European Union’s regulatory framework for in vitro diagnostics. Since the company manufactures Class A and IVD General devices, it must comply with EU regulations, including mandatory registration in the eudamed database—a central EU repository for IVD manufacturers and devices. This ensures transparency and traceability of its products within the EU market.

C.P.M. Compagnia per la Medicina S.r.l.’s devices are listed in the eudamed registry, the official EU database for in vitro diagnostics. This registry is critical because it provides authorized oversight of IVD manufacturers and their products, ensuring compliance with EU directives (e.g., IVDR). Listing in eudamed demonstrates that the company’s devices meet EU regulatory requirements, facilitating market access and traceability for healthcare professionals and authorities.

C.P.M. Compagnia per la Medicina S.r.l.’s devices fall under Class A (low-risk IVDs) and IVD General classifications. Class A devices are typically simple tests with minimal risk, such as certain reagents or calibrators, while IVD General refers to diagnostics not classified under higher-risk categories (e.g., self-tests or infectious disease assays). This classification determines the regulatory scrutiny required—Class A devices generally undergo less stringent evaluation than higher-risk classes, but all must still comply with EU IVDR requirements to ensure safety and performance.