Regulatory

We are committed to the future of electrophysiology

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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
FDA – K230803

Australia & New Zealand

TGA – 335022

Brazil

ANVISA – 81118639003

United Kingdom

UKCA –  759344

Canada

MDL – 111178

China

NMPA – 20232210618 

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

ADAS 3D around the world

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Fibrosis Imaging for the EP Lab

Contact Us
Phone: (+34) 93 209 41 48
Email: info@adas3d.com

Address:
Rambla Catalunya, 53, 4º-H                          08007 Barcelona, Spain

Call Us from:
Tuesday to Thursday: 9:00 AM – 1:00 PM

Outside these hours, please reach us at the email address.

 

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

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