Utrecht, Netherlands — 16th October 2024
ViCentra, an innovative leader in Diabetes technology, is proud to announce that its Kaleido insulin pump has received CE certification under the EU Medical Device Regulation (MDR) 2017/745. This milestone reinforces ViCentra’s commitment to provide high-quality, user-friendly solutions for people living with diabetes.
This certification follows an extensive preparation process followed by rigorous audits of ViCentra’s quality management system, and technical documentation. The Kaleido pump includes two durable pumps, a handheld, and consumables existing of an infusion set that lasts three days, and a choice between two insulin cartridges —either with a short tube that can be placed directly on the body, or a longer tube that allows the pump to be carried in the pocket.
Frans Cromme, CEO of ViCentra, stated, “We are proud to achieve CE certification under MDR for Kaleido. This milestone reflects our commitment to deliver a small and reliable insulin pump for insulin delivery, allowing users to live life with confidence and style.”
ViCentra’s dedication to innovation and quality is evident in every aspect of the Kaleido insulin pump. The design aims to empower users with a device that integrates seamlessly into their daily lives.
Desire Santiago, Director of Regulatory Affairs, added, “Receiving CE certification under the EU MDR is a testament to our rigorous quality standards and dedication to user safety. The Kaleido insulin pump meets the highest regulatory requirements, ensuring that we provide a safe and effective product for those living with diabetes.”
Achieving this CE certification ensures that Kaleido can continue to be marketed throughout the European Union and opens many other markets that require CE certification to apply for market access approval.
For more information about the Kaleido insulin pump and ViCentra’s vision for diabetes care, please visit www.hellokaleido.com