NuvoAir AB

NuvoAir AB specializes in respiratory devices. Their portfolio includes the NuvoAir Home system and the Air Next series, which appear to be designed for air purification or inhalation therapy at home or portable use. These devices are intended to support respiratory health applications.

NuvoAir AB is based in Sweden, as indicated by its country designation (SE). The company’s headquarters or primary operations are located within Sweden.

NuvoAir AB’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration is required for manufacturers to comply with EU medical device regulations and ensure transparency in the market.

NuvoAir AB’s devices fall under Class I and Class IIa classifications in the EU’s medical device regulatory framework. Class I devices are generally considered low-risk, while Class IIa devices involve a slightly higher risk and require additional conformity assessments to ensure safety and performance.