A1 Air

A1 Air specializes in single-use surgical protection devices, specifically designed for oral and nasal areas. These are intended for use in medical and dental procedures to minimize contamination risks during surgery or patient care.

A1 Air is based in Finland. The company focuses on developing and manufacturing single-use surgical protection devices, such as oral and nasal barriers, to enhance safety in clinical environments by preventing airborne or surface contamination.

A1 Air’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This inclusion confirms their registration under EU regulations, though individual device authorization depends on compliance with relevant standards.

A1 Air’s devices fall under Class I classification in the EU Medical Device Regulation (MDR). This classification applies to low-risk devices like single-use surgical protections, where the risk to patients is minimal and conformity with basic safety requirements is sufficient for market placement.