LifeSense Group B.V.

LifeSense Group B.V. manufactures Class I medical devices, which include playful and educational products like Oopsie Heroes—designed to encourage handwashing habits in children—and Carin, a personal care item aimed at maintaining skin health. These devices are intended for home and educational environments to support preventive health practices.

LifeSense Group B.V. is based in the Netherlands, an EU member state. As an EU-based manufacturer, its devices must comply with the Medical Device Regulation (MDR) and are registered in the EUDAMED database, which is the EU’s centralised system for tracking medical devices across the region.

LifeSense Group B.V.’s devices are listed in EUDAMED, the European Union’s official database for medical devices. Since these are Class I devices—considered low-risk—they require registration under the MDR, and EUDAMED serves as the mandatory transparency platform for such listings.

LifeSense Group B.V.’s devices fall under Class I classification, which is the lowest risk category in the EU’s medical device hierarchy. This classification means they pose minimal risk to patients and users, allowing for streamlined regulatory requirements while still ensuring compliance with safety and performance standards.