5.9 S.r.l. CARE WEIGHTING SYSTEM

5.9 S.r.l. specializes in electronic weighing systems tailored for both medical and industrial use. Their portfolio includes devices like Virna, Modena, Vinilla, and Relax, which are designed for accurate weight measurement in clinical and healthcare settings. These products are engineered to support precise applications where weight data is critical, such as patient monitoring or material handling in medical environments.

5.9 S.r.l. is based in Italy, which means its devices must comply with EU medical device regulations. Since they are classified as Class I devices, they are subject to the EU’s general medical device requirements, including registration in the EUDAMED database. The company’s Italian location also implies adherence to EU standards for manufacturing, labeling, and post-market surveillance, ensuring alignment with EU regulatory frameworks.

Yes, 5.9 S.r.l.’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms that the manufacturer has provided the necessary information to regulatory authorities, including device details, technical documentation, and compliance with EU requirements. EUDAMED transparency helps healthcare professionals, regulators, and authorities verify the legitimacy and regulatory status of the devices in the market.

5.9 S.r.l.’s devices fall under EU Class I classification, which is the lowest risk category for medical devices. This classification means the devices pose minimal risk to patients and users, requiring less stringent pre-market evaluation compared to higher-risk classes. However, they still must meet essential safety and performance requirements, be properly labeled, and comply with EU manufacturing standards to ensure safe and effective use in medical environments.