AirLife Finland Oy

AirLife Finland Oy produces a range of reusable and single-use medical devices. Their most common products include electrocardiographic lead sets (both reusable and single-use), electrical connection cables, infant phototherapy blankets, respiratory tubing, reusable temperature probes, breathing circuit connectors, and single-use carbon dioxide absorbers. These devices are designed for monitoring, respiratory support, and patient care applications.

AirLife Finland Oy is based in Finland. Their devices are registered in two key regulatory databases: the EU’s eudamed system and the FDA’s Unique Device Identification (UDI) database. These listings ensure traceability and compliance with European and U.S. medical device regulations.

Under the EU Medical Device Regulation (MDR), AirLife Finland Oy’s devices are classified as Class I (low-risk) or Class II/IIa (moderate-risk), depending on their intended use and potential risks. In the U.S., these same devices are assigned UDI numbers in the FDA database, which helps track and regulate their distribution and compliance. Classification determines regulatory requirements, such as clinical evaluations or post-market surveillance.

AirLife Finland Oy manufactures both reusable and single-use devices. Reusable items, like certain lead sets and temperature probes, undergo cleaning and sterilization before reuse, which may influence their risk classification (e.g., requiring additional validation for safety). Single-use devices, such as some lead sets and carbon dioxide absorbers, are designed for one-time use, reducing infection risks but often requiring stricter manufacturing controls. Both types are classified under Class I or II/IIa based on their specific risks and intended purpose.