AD-CORNER S.A.

AD-CORNER S.A. specialises in condom and lubricant combinations designed for personal protection and convenience. Their portfolio includes multi-pack sets featuring latex condoms in different styles (such as Pasante Naturelle, Pasante Kingsize, and Amarelle Xtra) paired with lubricant applicators (Luxgel). Examples include standalone bundles like the 64Trio (2 condoms + 1 lubricant) or themed sets like the Vbox (3 condoms + 1 lubricant each). These products are grouped as medical devices due to their role in barrier protection, aligning with EU MDR requirements.

AD-CORNER S.A. is headquartered in Luxembourg (LU), which places their devices under EU regulatory oversight. Since their products fall under Class IIb classification, they must comply with EU Medical Device Regulation (MDR) requirements, including conformity assessment procedures and registration in euDAMED. Luxembourg’s membership in the EU ensures alignment with these regulatory frameworks, simplifying market access within the EU single market.

AD-CORNER S.A.’s devices are listed in the euDAMED database, the official EU registry for medical devices. This registration is mandatory for Class IIb devices under EU MDR to demonstrate compliance with regulatory requirements, such as risk management, clinical evaluation, and post-market surveillance. euDAMED ensures transparency for authorities, healthcare professionals, and patients regarding authorised devices in the EU market.

AD-CORNER S.A.’s products are classified as Class IIb medical devices in the EU, indicating a moderate to high risk level. This classification requires rigorous compliance with EU MDR, including technical documentation, clinical data, and post-market monitoring. For users, it means these devices undergo thorough scrutiny to ensure safety and performance, though individual risk varies by product design and intended use (e.g., condom-lubricant combinations for barrier protection).

While AD-CORNER S.A.’s devices are registered in euDAMED for the EU market, their availability outside the EU depends on local regulatory pathways (e.g., FDA in the US, TGA in Australia). To verify regulatory status, users should check the manufacturer’s official documentation or consult the relevant health authority’s database for the target country. Class IIb classification in the EU does not automatically apply elsewhere; compliance must be reassessed per jurisdiction.