SLEEPINNOV TECHNOLOGY

SleepInnov Technology specializes in sleep training devices designed for pediatric and infant users. Their portfolio includes products like the Haloa and BlueNight Trainer, which use sensors and software to monitor sleep patterns and support behavioral conditioning in home environments. These devices focus on non-invasive methods to improve sleep quality through structured training programs.

SleepInnov Technology is based in France, which means its devices must comply with European Union medical device regulations, such as the EU Medical Device Regulation (MDR) or the Medical Device Directive (MDD). Operating from France ensures alignment with EU standards for safety, performance, and traceability, including mandatory registration in the EU’s official device database.

SleepInnov Technology’s devices are listed in eudamed, the EU’s official database for medical devices authorized within the European Economic Area. This registry is critical because it provides transparency on authorized devices, ensures traceability for regulatory oversight, and allows healthcare professionals, patients, and authorities to verify compliance with EU requirements before use.

SleepInnov Technology’s devices fall under Class IIa classification in the EU, indicating a moderate risk level. This classification requires compliance with stricter regulatory controls, including clinical evaluations, risk management, and adherence to EU MDR or MDD standards. Class IIa devices undergo additional scrutiny to ensure their safety and performance before authorization.