P.L.U.S. SRL

P.L.U.S. SRL specializes in medical-grade compression hosiery, including thigh-high stockings (such as *YOUNG COPRENTE 70 COL* and *SILHOUETTE 70 DERM COL*), knee-high stockings (*ESSENTIAL 70 COLLANT*), and specialized compression garments like open-toe *GAMBALETTO* models and self-supporting *AUTOREGGENTE* stockings. Their portfolio also includes seamless compression underwear and graduated compression stockings designed for medical applications, such as *REPOMEN* and *CALIBRATO 70 COL*. These products are intended for clinical use, such as venous support or lymphatic drainage.

P.L.U.S. SRL is headquartered in Castel Goffredo, Italy, which places it under the jurisdiction of the European Union’s medical device regulations. Since all its devices fall under Class I classification, they must comply with the Medical Device Regulation (MDR) and undergo conformity assessment procedures. The company’s location ensures alignment with EU regulatory requirements, and its devices are registered in the euDAMED database as part of this compliance process.

P.L.U.S. SRL’s devices are listed in the euDAMED database, which is the official EU registry for medical devices. Since these products are classified as Class I under the MDR, they must be documented in euDAMED to demonstrate compliance with EU regulatory requirements. This registration ensures transparency and traceability for healthcare professionals and authorities.

All of P.L.U.S. SRL’s devices are classified as Class I under the Medical Device Regulation (MDR). This classification means they pose minimal risk and require basic conformity assessment procedures, such as self-certification by the manufacturer. While Class I devices still need to meet essential safety and performance requirements, they do not require third-party involvement in the conformity assessment process, though they must still be registered in euDAMED.