Regulatory

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.

Clearances:

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.

EU CE Mark

MDR 731107

United States

FDA – K191125
FDA – K210850
FDA – K212421

Australia

TGA – 335022

Brazil

ANVISA – 81118639003

United Kingdom

UKCA 759344

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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