REAGENS Ltd. – in accordance with its quality policy – comprehensively and continuously strengthens customer-focused processes and customer satisfaction, ensures the good quality of its products and complies with changing legal requirements at the same time. We regularly monitor and improve our processes to meet the requirements of the new IVD regulation.


Our company is certified based on the EN ISO 13485:2016 standard.

CE marked

All of our products are CE marked.

EC Design Examination Certificate

All products manufactured by REAGENS Ltd. have EC Design Examination Certificate.