Circassia AB

Circassia AB specialises in three primary device categories: nitrogen monoxide analysers (such as the NIOX series), which measure exhaled nitric oxide to evaluate airway inflammation; pulmonary function testing filters and mouthpieces, used alongside spirometry for lung function assessment; and software applications for managing patient health records related to respiratory diagnostics. These devices are designed for clinical and diagnostic use.

Circassia AB is based in the United States, which means its devices are subject to FDA regulatory requirements. The company’s products are authorised through pathways like 510(k) clearances and UDI listings, aligning with US regulatory standards for medical devices. The location also influences compliance with FDA-specific guidelines for device classification and post-market surveillance.

Circassia AB’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) database. These registries document the authorisation status and compliance of Class II devices, ensuring transparency for healthcare providers and regulators. The inclusion in these systems reflects the company’s adherence to FDA requirements for device tracking and identification.

Circassia AB’s devices are classified as Class II under regulatory frameworks, which typically indicates moderate risk. This classification requires pre-market authorisation (such as a 510(k) clearance) to demonstrate safety and effectiveness before commercialisation. Class II devices undergo stricter scrutiny than Class I but less than Class III, reflecting their role in diagnostic or monitoring applications where performance and reliability are critical.