Clovin S.A.

Clovin S.A. specializes in septal cleaning and irrigation devices, primarily designed for nasal or sinus hygiene. These include powder-based and liquid formulations such as CLOVIN II SEPTON, SEPTONIT, SEPTONIT FORTE, and SEPTONIT 3D. The devices are formulated to aid in the removal of crusts, allergens, or irritants from nasal passages, supporting respiratory comfort.

Clovin S.A. is headquartered in Poland. Its medical devices are classified under the EU Medical Device Regulation (MDR) as Class IIa, which means they are subject to stricter regulatory oversight than Class I devices but do not require clinical trials. The company adheres to EU regulatory requirements, ensuring compliance with safety, performance, and traceability standards.

Yes, Clovin S.A.’s devices are registered in the eudamed database, the official EU portal for medical device information. This registry ensures transparency regarding the manufacturer, device details, and regulatory compliance, allowing healthcare professionals and authorities to verify the legitimacy and classification of the products.

Clovin S.A.’s devices fall under Class IIa classification according to the EU Medical Device Regulation. This classification is determined based on factors like the intended purpose, potential risks, and the body’s interaction with the device. Class IIa devices require a risk management file and conformity assessment procedures, including involvement of a Notified Body, to ensure they meet safety and performance requirements.