BECAUSE WE PUT QUALITY FIRST
The quality and certification of our products occupy a central place in our priorities, thus guaranteeing the well-being of our users. Also, as with any medical device, LORIO is subject to rigorous standards which guarantee the safety of its users. At HAPPLYZ Medical, we are committed to protecting patient health data with the utmost rigor, thus ensuring an uncompromising care experience.
MEDICAL
CERTIFICATIONS
LORIO is a Class I CE-certified medical device.
It has been developed in compliance with European regulation 2017/745.
BIO-COMPATIBILITY
The plastic components of our flute are all bio-compatible and can be placed in the mouth without risk to the user.
DATA MANAGEMENT (RGPD)
Each user's medical data is hosted on an HDS (Health Data Hosting) certified server. Our supplier's servers are located in France, guaranteeing the sovereignty of the data stored.
THEN WHAT ABOUT HYGIENE ?
At HAPPLYZ MEDICAL, patient safety is one of our top priorities, particularly when it comes to hygiene. Aware of the risks associated with respiratory conditions, we have implemented a strict sterilization protocol for the mouthpieces, developed in collaboration with a hygiene specialist from a Cystic Fibrosis Resource and Competence Center.
In addition, the device’s mouthpiece has been specifically designed to accommodate single-use antimicrobial filters, ensuring optimal protection against cross-contamination. A document outlining our hygiene protocol is available as an attachment for healthcare professionals.
