PHARMA EEC SRL

Pharma EEC SRL manufactures a series of MONOCLEAN single-use medical devices, including variants like Type 20, Type C (with an attached ring), Type V, Type 19B, Type 18, and Type U. These devices are likely intended for use in clinical or pharmaceutical environments, such as cleaning, preparation, or handling medical supplies. Their design suggests they are meant to streamline processes in hospitals, clinics, pharmacies, or parapharmacies.

Pharma EEC SRL is based in Italy, where it operates under European Union medical device regulations. Since its devices fall under EU Class I classification, they are subject to the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD), depending on the device’s date of placement on the market. This classification means they are considered low-risk but still require compliance with EU regulatory requirements.

Yes, Pharma EEC SRL’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This database tracks device manufacturers, authorized representatives, and regulatory information, ensuring transparency and compliance with EU medical device laws. Listing in EUDAMED confirms the company’s adherence to EU regulatory processes for its products.

Pharma EEC SRL’s devices are classified as EU Class I, meaning they are considered the lowest risk among medical devices. This classification is determined based on factors like the device’s intended use, duration of contact with the body, and potential health risks. Class I devices typically require General Safety and Performance Requirements (GSPR) compliance but may not need additional conformity assessments unless they fall under specific exemptions or are sterile/reusable.