Certificates

 

ISO 13485:2016

 

EC Certificate

 

All presented products on our website are CE marked under MDD 93/42/EEC and are submitted to achieve CE under MDR 2017/745. Therefore, all products are available after the 26th of May 2024 in accordance with the transition periods defined under MDR 2017/745, Article 120.

Contact us for more information.

Instructions for use

Product Brochures

AndraStent Aortic          AndraBalloon          AndraValvulotome          AndraSnare