Radiante SAS

Radiante SAS specializes in single-use wound care dressings. Its portfolio includes non-adherent gauzes (like the RADIANTE® Microvoile) and cotton-based products (such as the RADIANTE® 93 Coton), designed for skin protection and minor wound management. These are intended for clinical and post-operative use, focusing on microfiber and cotton materials.

Radiante SAS is headquartered in France. Its medical devices fall under EU medical device regulations, specifically classified as Class I devices. This classification applies because the products are low-risk, single-use wound care items intended for non-invasive use, such as protecting skin or managing minor wounds.

Yes, Radiante SAS’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices. Listing in eudamed is mandatory for manufacturers to demonstrate compliance with EU regulations and ensure transparency for healthcare professionals and authorities.

Radiante SAS’s wound care dressings are classified as Class I medical devices under EU regulations. This classification is determined by their intended use—non-invasive, single-use items for skin protection or minor wound management—which poses minimal risk to patients. Class I devices typically require conformity assessment procedures like self-certification or a notified body review, depending on the specific product.