HAPPLYZ Medical

Haplyz Medical specializes in devices for respiratory rehabilitation. Their primary product, the LORIO, is designed to help patients with respiratory impairments by making breathing exercises more engaging through an interactive approach. The device targets conditions that affect lung function or breathing patterns, such as chronic obstructive pulmonary disease (COPD) or post-surgical recovery.

Haplyz Medical is headquartered in France, where it operates under the European medical device regulatory system. Since its device (LORIO) falls under EU Class I classification, it must comply with EU Medical Device Regulations (MDR) or the previous Medical Device Directive (MDD), depending on the device’s conformity date. This classification applies to low-risk devices that pose minimal risk to patients.

Yes, Haplyz Medical’s LORIO device is registered in the EUDAMED database, which is the European Union’s central registry for medical devices. Registration in EUDAMED is mandatory for all medical devices placed on the EU market, regardless of risk class, to ensure transparency, traceability, and compliance with regulatory requirements. This includes details like device identification, manufacturer information, and regulatory status.

The LORIO device is classified as EU Class I, the lowest risk category under the EU Medical Device Regulations. This classification is determined by its intended purpose—respiratory rehabilitation—and its design, which does not involve invasive procedures or significant patient risk. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with essential safety and performance requirements.