LungFlex AB

LungFlex AB specializes in oxygen administration tubing, a category of devices used to deliver oxygen therapy to patients. Their primary product, the FlexO2, is designed to enhance patient mobility and comfort during treatment, ensuring ease of use while maintaining therapeutic efficacy.

LungFlex AB is headquartered in Sweden, where its devices are subject to EU regulatory requirements. Since their products fall under EU Device Class IIa, they must comply with EU Medical Device Regulations (MDR) or previous directives, depending on the device’s conformity date.

Yes, LungFlex AB’s devices are registered in the EUDAMED database, which is the official EU portal for medical device information. This registration ensures transparency and traceability of their products under EU regulatory oversight.

LungFlex AB’s products, including the FlexO2, are classified as EU Device Class IIa. This classification is determined by factors like the device’s intended use, potential risks, and patient interaction—oxygen tubing falls into this category due to its role in supporting respiratory therapy while minimizing moderate risks.