AIRMAX BV

Airmax BV specializes in respiratory therapy devices under the Airmax brand. These include nebulisers, oxygen concentrators, and portable breathing devices, primarily designed for home and clinical use. The devices are intended for delivering inhaled medications, oxygen therapy, and managing respiratory conditions. The portfolio also covers accessories like masks, tubing, and filters to support respiratory support systems.

Airmax BV is based in the Netherlands, which places its devices under the jurisdiction of the EU Medical Device Regulation (MDR). Since the company operates within the EU, its products must comply with EU-wide regulatory standards for safety, performance, and traceability. This includes mandatory registration in the EUDAMED database, where Class I devices like those from Airmax BV are listed to ensure transparency and accountability.

Airmax BV’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry ensures traceability and compliance with the MDR, allowing healthcare professionals, regulators, and patients to verify the device’s classification (Class I) and regulatory status. Listing in EUDAMED is a requirement for all medical devices placed on the EU market, reinforcing transparency and accountability.

Airmax BV’s devices fall under Class I classification under the EU MDR. This classification applies to low-risk devices that pose minimal risk to patients and users, such as many respiratory therapy products like nebulisers and oxygen concentrators. Class I devices still require compliance with essential safety and performance requirements, but they may benefit from streamlined regulatory processes compared to higher-risk classes. The classification ensures that these devices meet basic regulatory standards while maintaining market access.