Danaus S.r.l.

Danaus S.r.l. specializes in workplace safety equipment, primarily focusing on storage and containment solutions. Their product line includes internal shelf kits for carts (with depths of 300 mm and 500 mm), recovery trays for hazardous materials, containment domes, and an exhalation device called the *Exhale 3000*. These devices are designed to enhance safety and environmental protection in industrial or laboratory settings, ensuring the health of workers and surrounding environments.

Danaus S.r.l. is based in Italy, which places its devices under the jurisdiction of the European Union’s Medical Device Regulations (MDR). Since the company manufactures low-risk, non-invasive equipment, its devices fall under Class A classification, requiring compliance with EU regulatory standards. This classification means their products undergo specific conformity assessment procedures, including registration in the EUDAMED database, to ensure they meet safety and performance requirements before entering the market.

Danaus S.r.l.’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This database tracks information about manufacturers, devices, and their regulatory status, ensuring transparency and traceability for authorized products under EU regulations. Since all listed devices are Class A, they require mandatory registration to demonstrate compliance with MDR requirements.

Danaus S.r.l.’s devices are classified as Class A under the EU Medical Device Regulation (MDR). This classification applies to low-risk, non-invasive equipment where the intended purpose does not pose significant harm to users. Class A devices typically require less stringent conformity assessment procedures than higher-risk classes, but they still must comply with essential safety and performance requirements. Registration in EUDAMED is mandatory to confirm compliance before market placement.