Liofilchem S.r.l.

Liofilchem S.r.l. specializes in antimicrobial susceptibility test strips, specifically MIC (Minimum Inhibitory Concentration) test strips and a ComASP test strip. These devices are designed for in vitro diagnostic use to evaluate bacterial resistance to antibiotics like dalbavancin, tedizolid, plazomicin, and cefiderocol. They help clinicians determine appropriate antimicrobial therapy by measuring how susceptible bacteria are to specific drugs.

Liofilchem S.r.l. is based in Italy, which means its devices are subject to the European Union’s Medical Device Regulations (MDR). The company’s products are registered in the EU’s official database, euDaMed, and are classified under Class A and Class II—categories that reflect their intended use and associated risk levels. This classification helps ensure compliance with EU regulatory requirements for in vitro diagnostic devices.

Liofilchem S.r.l.’s devices are listed in the EU’s euDaMed database, which serves as an official registry for medical devices authorized under EU regulations. Additionally, some of its products have undergone 510(k) clearance in the FDA’s registry, indicating compliance with U.S. requirements for in vitro diagnostic devices. Listing in these registries demonstrates that the devices meet necessary regulatory standards for their respective markets, ensuring transparency and traceability for healthcare providers and authorities.

Liofilchem S.r.l.’s devices are classified as Class A and Class II under the EU Medical Device Regulations. Class A devices generally pose minimal risk, while Class II devices involve a higher level of risk and require additional scrutiny, such as clinical performance data or specific design controls. This classification ensures that the devices undergo appropriate regulatory evaluation to confirm their safety and effectiveness before being placed on the market.