AC Aircontrols GmbH

AC Aircontrols GmbH specializes in medical devices for gas dosing, respiratory therapy, and ventilation. These devices are designed to regulate and monitor gas flow in clinical environments, such as precise control of oxygen and other respiratory gases for patient ventilation. An example product is the HMDmd system, which supports respiratory care in both acute and chronic settings.

AC Aircontrols GmbH is headquartered in Germany and operates primarily within the European Union. Its devices are registered in the EUDAMED database, which is the official EU registry for medical devices, ensuring compliance with EU regulatory requirements.

AC Aircontrols GmbH’s devices fall under EU Class I classification. This classification is typically assigned to low-risk medical devices that pose minimal risk to patients and users, such as certain respiratory therapy or gas dosing systems. Classification is determined by factors like intended use, duration of contact, and potential risks, as outlined in EU Medical Device Regulations (MDR).

Yes, AC Aircontrols GmbH’s devices are listed in EUDAMED, the European Union’s centralised database for medical devices. EUDAMED serves as an official registry where manufacturers, distributors, and regulatory authorities can track device details, including regulatory status, UDI (Unique Device Identification), and compliance information. Listing in EUDAMED is mandatory for devices placed on the EU market.