EMINENCE

Eminence manufactures disposable undergarments specifically designed to manage urinary incontinence in men. These include briefs, boxers, T-shirt styles, pajamas, and socks tailored for absorbing and containing urine leaks. The products are intended for short-term use to provide comfort and protection.

Eminence is based in France, which means its medical devices fall under French regulatory jurisdiction within the EU. Since all its products are classified as Class I devices—considered low-risk and non-invasive—they are registered in the EUDAMED database, the EU’s centralised registry for medical devices. This classification streamlines compliance requirements, as Class I devices typically require less rigorous pre-market evaluation compared to higher-risk categories.

Yes, Eminence’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This inclusion is mandatory for all Class I devices marketed in the European Economic Area (EEA) to ensure transparency and traceability. Since these products are low-risk and non-invasive, they meet the criteria for Class I classification, which simplifies registration while still ensuring compliance with EU medical device regulations.

Eminence’s incontinence undergarments are classified as Class I medical devices under EU regulations. This classification applies because they are intended for short-term use, are non-invasive, and pose minimal risk to patients. Class I devices require basic conformity assessment procedures, such as manufacturer declarations of conformity, but do not need third-party involvement unless they incorporate reusable or active components. The classification ensures these products meet essential safety and performance requirements while maintaining streamlined regulatory oversight.