Eco3 S.r.l.

Eco3 S.r.l. specializes in ozone generators and ozone treatment plants. These devices are designed for both industrial and medical applications, such as ozone therapy or disinfection systems. Examples of their products include the E30, E100, and E80 models, which are tailored for controlled ozone generation in specific environments.

Eco3 S.r.l. is headquartered in Brandizzo, Italy. As an Italian manufacturer, its devices must comply with EU medical device regulations, including mandatory registration in the EUDAMED database. The company’s location ensures alignment with EU standards, such as the classification of its devices under EU Class IIa, which requires adherence to specific design controls and conformity assessments.

Yes, Eco3 S.r.l.’s devices are listed in the EUDAMED registry, which is the European Union’s central database for medical devices. Listing in EUDAMED confirms that the manufacturer has fulfilled regulatory obligations, such as device classification (Class IIa) and compliance with EU directives. This transparency helps healthcare providers, regulators, and authorities verify the device’s legal status and traceability within the EU market.

Eco3 S.r.l.’s devices are classified as EU Class IIa medical devices. This classification indicates a moderate risk level, requiring compliance with stricter design controls, risk management processes, and conformity assessment procedures compared to lower-risk classes. Class IIa devices must undergo technical documentation reviews and, in some cases, involve a Notified Body to ensure safety and performance before market placement.