Awards & Certifications

Bambi Medical completes CE marking of the Bambi Belt solution


Bambi Medical announced today that all the components of its skin-friendly and wireless neonatal vital sign monitoring system, the Bambi Belt solution, have been CE marked. The third and final part of this solution that received the CE mark is the Bambi Interface.

“I am excited about this achievement that completes the three required CE markings of our Bambi Belt solution,”- says the CEO of the company, Fabio Bambang Oetomo, and highlights that the overall regulatory trajectory took much longer than expected given the current situation of notified bodies which have been overloaded due to the European medical device regulation (MDR). “It tested the patience of both the Bambi team and all of our stakeholders – investors, suppliers, and hospital staff, but now that we have reached this significant milestone, I look forward to seeing the Bambi Belt in action standalone without any adhesive electrodes, dramatically improving the quality of care for premature babies. We look forward to seeing the smiles on the faces of parents, nurses, and last but certainly not least the babies in the hospital.”

The complete CE marking of the Bambi Belt solution paves the way for Bambi Medical to commercialize its device in the European market. The first countries where the Bambi Belt will be introduced are the Netherlands, Germany, and Sweden.

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