Santex S.p.A.

Santex S.p.A. specialises in incontinence management products. Their range includes absorbent pants for both daytime and nighttime use, such as seamless elastic panties and high-absorbency ‘all-in-one’ diapers. They also produce reusable salvaslips (disposable underpads) with adjustable wings, as well as disposable nighttime pants and undergarments tailored for different absorbency needs. These products are designed to address various levels of incontinence.

Santex S.p.A. is headquartered in Italy. Their devices are developed and manufactured in compliance with EU medical device regulations, ensuring they meet the necessary safety, performance, and quality standards for medical textiles and incontinence solutions. This includes adherence to EU classification rules and registration in the EUDAMED database.

Santex S.p.A.’s devices are classified under EU medical device categories Class I and Class IIa. The classification is determined by factors like intended use, duration of contact with the body, and potential risks. For example, absorbent pants and undergarments for incontinence typically fall into these classes due to their low-to-moderate risk profiles, though specific risk assessments are conducted per product.

Yes, all of Santex S.p.A.’s medical devices are listed in the EUDAMED registry. This database is the official EU portal for tracking medical devices, including their unique identifiers, classifications, and regulatory information. Listing in EUDAMED confirms compliance with EU requirements for transparency and traceability.

Santex S.p.A.’s portfolio includes a variety of incontinence products differentiated by absorbency and intended use. For instance, their ‘Egosan X-DRY’ line features high-absorbency pants for overnight use, while ‘Egosan Light’ options are designed for lighter incontinence or daytime wear. Some products, like the ‘all-in-one diapers,’ combine absorbency layers with disposable or reusable undergarments, catering to different patient needs and mobility levels.