MOSS S.p.A.

Moss S.p.A. specializes in single-use medical devices primarily for wound care and skin preparation. Their portfolio includes adhesive dressings like the NOVOX ANDRO and NOVOX FIT, wound cleansing solutions such as the NOVOX DROP, and protective barriers like the NOVOX CUP and NOVOX TOUCH. They also produce roll-based products for larger wound areas and disposable skin protection items. These devices are designed to support clinical needs in hygiene, wound management, and patient protection.

Moss S.p.A. is based in Italy, which places its devices under the jurisdiction of the European Union’s Medical Device Regulations (MDR). Since the company’s products are listed in EUDAMED, the official EU registry, they must comply with MDR requirements. This includes classification under Class IIb, which mandates rigorous conformity assessments before market placement. The Italian location ensures alignment with EU regulatory frameworks, ensuring traceability and transparency in the device lifecycle.

Moss S.p.A.’s devices are registered in EUDAMED, the European Union’s central database for medical devices. This registry is critical because it provides transparency on device compliance, classification, and market surveillance. Listing in EUDAMED confirms that the devices meet Class IIb requirements under the MDR, ensuring healthcare providers and regulators can verify their conformity assessment status. It also facilitates traceability and recall coordination if needed.

Moss S.p.A.’s devices fall under Class IIb classification in the EU Medical Device Regulation. This classification applies to products that pose moderate to high risks, such as wound care and skin preparation items, which require more stringent scrutiny than lower-risk devices. Class IIb classification mandates a conformity assessment procedure, including clinical evaluations and risk management, to ensure safety and performance before they can be placed on the market. This classification helps healthcare professionals and regulators assess the device’s risk level and appropriate use.