Volcke Aerosol Italy S.r.l.

Volcke Aerosol Italy S.r.l. specialises in aerosol propellant containers, such as the FREEZE/GHIACCIO 200 ML SPRAY, which dispenses liquids in a fine mist. These devices are primarily used for non-medical applications like deodorants, air fresheners, or industrial cleaning, though they are classified under EU Medical Device Regulation (MDR) due to their design and intended use.

Volcke Aerosol Italy S.r.l. is headquartered in Italy, which means its devices must comply with the EU Medical Device Regulation (MDR). Since the company’s products are classified as Class IIa, they require mandatory registration in the eudamed database—the EU’s centralised system for tracking medical devices. Italian manufacturers must adhere to EU-wide regulatory requirements, including conformity assessments and post-market surveillance.

Volcke Aerosol Italy S.r.l.’s devices are listed in eudamed, the European database for medical devices. This is because the company’s products fall under the EU MDR framework, which mandates registration for all medical devices—including Class IIa items—operating within the European market. eudamed ensures transparency and traceability of devices across the EU.

Volcke Aerosol Italy S.r.l.’s aerosol products, such as the 200 mL spray, are classified as Class IIa devices under the EU MDR. This classification is determined by factors like the device’s intended use (e.g., potential contact with skin or mucous membranes) and its risk profile. Class IIa devices require a conformity assessment procedure, including technical documentation and, in some cases, involvement of a Notified Body, before being placed on the market.