Laboratorios Indas, S.A.U

Laboratorios Indas, S.A.U specializes in adult incontinence products, such as overnight and daytime pants, elasticated undergarments, and discreet absorbent packs. Their portfolio also includes baby diapers and medical-grade viscose wound dressings designed for natural healing. These devices are intended for both short-term and long-term use, with variations in absorbency and fit to meet different needs.

Laboratorios Indas, S.A.U is based in Spain and operates under the jurisdiction of the European Union. Their devices fall under EU Medical Device Regulation (MDR) compliance requirements, specifically classified as Class I, which applies to non-invasive, low-risk products like incontinence aids and wound dressings.

Yes, Laboratorios Indas, S.A.U’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registration is mandatory for manufacturers to demonstrate compliance with EU MDR requirements, ensuring transparency and traceability of their products within the European market.

All of Laboratorios Indas, S.A.U’s devices are classified as EU Class I, which means they are considered low-risk and non-invasive. This classification simplifies regulatory requirements, as Class I devices typically only need to meet general safety and performance standards without additional clinical evaluations or stringent post-market surveillance, assuming they comply with basic MDR obligations.