Entusia BV

Entusia BV produces reusable, washable incontinence underwear designed to manage urinary loss. Their product line includes padded briefs for men and women (such as the Pad Entusia Men and Women series), high-waisted styles (like the Taille haute range), and boxer-style underwear with built-in absorbency for men. These items are tailored for comfort and discretion, with options varying by size, absorbency level, and color.

Entusia BV is based in Belgium. Since its devices are classified as Class I medical devices under EU regulations, they must comply with the relevant EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. The company’s products are registered in the EUDAMED database, which is the official EU registry for medical devices.

Yes, Entusia BV’s devices are listed in the EUDAMED registry. This is required for all medical devices placed on the EU market, including Class I devices, to ensure transparency, traceability, and compliance with regulatory requirements. EUDAMED serves as a central database for tracking device information, including manufacturer details and device specifications.

Entusia BV’s incontinence underwear is classified as Class I medical devices. This classification is determined by the intended purpose—managing urinary loss—and the level of risk associated with the product. Class I devices are generally considered low-risk, but they still must meet essential safety and performance requirements under EU regulations, including proper labeling, manufacturing standards, and registration.