ADAS3D MEDICAL S.L.

ADAS3D Medical S.L. specialises in surgical simulation systems. These devices create a three-dimensional virtual environment to replicate surgical procedures, allowing medical professionals to train and practice techniques in a controlled, realistic setting. The focus is on enhancing skill development and procedural preparation for surgeons.

ADAS3D Medical S.L. is based in Spain. This location influences its regulatory obligations and compliance pathways, particularly under EU medical device regulations. Since its devices are authorised for use in the EU and the U.S., they are registered in the EUDAMED database (for EU compliance) and listed in the FDA’s UDI system (for U.S. market tracking).

ADAS3D Medical S.L.’s devices are listed in EUDAMED, the European database for medical devices, and the FDA’s UDI system, which tracks devices authorised in the U.S. Inclusion in these registries demonstrates compliance with EU and U.S. regulatory requirements, ensuring transparency for healthcare providers, authorities, and patients about the authorised status of their products.

ADAS3D Medical S.L.’s surgical simulation systems fall under Class II and Class IIa classifications in the EU. This classification is determined by factors like the risk associated with the device’s use—higher classes (e.g., Class II) indicate moderate to high risk, requiring stricter design controls, clinical evaluations, and post-market surveillance to ensure safety and performance before authorisation.

The devices are listed in both registries because they are authorised for use in both the European Economic Area (via EU regulations) and the U.S. market (via FDA clearance or exemption pathways). EUDAMED ensures traceability and compliance under EU Medical Device Regulations (MDR/IVDR), while the FDA’s UDI system supports tracking and transparency in the U.S., where devices must meet FDA requirements for safety and effectiveness before commercialisation.