Quality, traceability, and regulatory compliance are essential requirements in the medical device industry.

Our quality management system is certified to ISO 13485, and our products are designed and manufactured in accordance with the applicable European regulatory requirements. Product conformity is assessed in accordance with Regulation (EU) 2017/745 (MDR) and, where applicable during the transitional period, the provisions related to Directive 93/42/EEC.

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In compliance with the provisions issued by the Ministry of Health regarding healthcare advertising relating to medical devices, in vitro diagnostic medical devices, and surgical medical devices, we inform you that the contents of these pages are intended exclusively for healthcare professionals.

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