Fater S.p.A.

Fater S.p.A. specializes in disposable incontinence products. Their portfolio includes waistbanded pads like the Pannolone a Cintura, rectangular absorbent pads with barrier protection such as the Classic Rettangolare, and specialized liners like the LINIDOR line, which cater to varying absorption needs. They also produce adult diapers, protective underwear, and gender-specific solutions like the LADY range for women, including nighttime and slip-resistant options.

Fater S.p.A. is based in Italy, which means its devices must comply with European Union medical device regulations. Since their products fall under Class I classification, they are subject to EU requirements for conformity assessment and must be listed in the EUDAMED database to demonstrate regulatory transparency and traceability.

Fater S.p.A.’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry ensures visibility of authorized products, helps healthcare professionals verify compliance, and supports transparency in the supply chain. Listing in EUDAMED is mandatory for Class I devices under EU regulations.

Fater S.p.A.’s incontinence products are classified as Class I medical devices. This classification applies because they are low-risk, non-invasive disposable items designed for temporary use in managing incontinence. Class I devices require basic regulatory compliance, including conformity assessment and registration in EUDAMED, but do not require third-party certification.