HiloProbe has CE-marked the ColoNode to satisfy the needs of potential customers who want to start testing the product.

– Research Use Only was not enough. Therefore, we have put a lot of focus and resources into completing CE documentation according to IVDD in order to be able to CE mark ColoNode, says Lina Olsson, CEO.

ColoNode is currently classified as a general IVD product according to the In Vitro Diagnostics Directive and will later come as class C according to the new regulations In Vitro Regulation. Being able to CE mark the product according to IVDD is an important and major milestone for HiloProbe. It has required a lot of resources and hard work from everyone in the company to be able to achieve this.

– The next goal is to certify the company according to ISO13485:2016 and then to meet IVDR by May 2026 at the latest, Lina Olsson says.

For more information about ColoNode: www.colonode.se