We are committed to the future of electrophysiology

Consult our regulation

We apply a regulatory compliance strategy dedicating specific resources to monitoring the state of the art, regulations and applicable standards in all geographic jurisdictions where we commercialise our products.


Adas 3D Medical S.L holds globally recognized ISO 13485:2016 certifications from prestigious British Standards Institution (BSI). In addition to ISO 13485:2016, the company quality system is established and maintained to comply with Medical Device Regulation (EU)2017/745, Australian TherapeuticGoods (Medical Devices) Regulations and US FDA Quality System Regulations, 21 CFR Part 820.

United Kingdom

MD 714518

Adas3D Medical SL has obtained the ISO certification with number MD 714518

Australian sponsor:
KD & A Pty Ltd
286 Flinders Street, Adelaide, SA, 5000. Australia

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