Not Experimental Anymore: Kitazato’s Ultra-Fast Warming Kit is Now CE Marked

This month, we’re celebrating a major breakthrough in cryopreservation with the official launch of our Ultra-Fast Warm Kit, now proudly CE marked under the stringent EU Medical Device Regulation (MDR). This achievement is not just a milestone; it’s a testament to our relentless pursuit of excellence, safety, and innovation in reproductive technology.

CE Mark: A Seal of Trust and Quality

Achieving the CE mark is more than a regulatory milestone; it’s a hallmark of our commitment to setting the highest standards in the industry. This certification ensures that the Ultra-Fast Warming Kit meets the rigorous demands of the EU’s regulatory framework, reflecting our dedication to providing you with tools that enhance your practice and deliver the best possible outcomes for your patients. Now, with this official seal of approval, the Ultra-Fast Warming Kit is available to healthcare professionals and patients throughout the European Union, with global availability subject to local regulations.

A Quantum Leap in Cryopreservation

The Kitazato Ultra-Fast Warm Kit is designed for precision and speed, engineered to excel in the ultra-fast warming of vitrified human oocytes and embryos. Our team has subjected this kit to exhaustive testing and rigorous evaluations, ensuring it surpasses the highest standards of quality and safety. The result? A revolutionary product that delivers unparalleled performance, offering a seamless transition from cryopreservation to viability.

What’s Next?

We want to inform you that production of the new Kitazato Ultra-Fast Warming Kits and their accompanying Instructions for Use (IFUs) will begin soon, with full availability expected in the EU by the end of September and availability in other markets subject to local regulatory requirements.

Kitazato Ultra-Fast Warming procedure is now a reality with all the scientific and regulatory reassurance. For more information, connect with us at info@dibimed.com. And don’t miss our informational flyer for all the exciting details.