Circassia AB
SwedenFDA applicant, unverified
Circassia AB is a medical device manufacturer, with 25 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II) as of 15 Nov 2026.
- Devices
- 25
Registry facts
- Registries
- FDA GUDID 24
- EUDAMED 4
- FDA 510(k) 1
- Device classes
- FDA Class II 25
- Identifiers
- DUNS 632700860
What Circassia AB makes
Circassia AB develops nitrogen monoxide analysers, such as the NIOX series, which measure exhaled nitric oxide levels to assess airway inflammation and respiratory conditions. They also produce pulmonary function testing devices, including mouthpieces and filters, used alongside spirometry to evaluate lung function. Additionally, the company offers software applications for managing patient health records related to respiratory diagnostics.
The company’s devices are classified as Class II under regulatory frameworks, with several authorised through FDA pathways including 510(k) clearances and UDI listings. These products are intended for use in clinical and diagnostic settings, adhering to US regulatory standards.
Catalogue
Search and filter all 25 devicesCompany details
- DUNS number
- 632700860
- Phone
- 1 (866) 275-6469
Frequently asked questions
How many devices does Circassia AB have in the registry?
The registry currently lists 25 devices for Circassia AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Circassia AB's devices?
Among its 25 most recently registered devices, Circassia AB has devices listed in EUDAMED (4 devices), FDA 510(k) (1 device) and FDA GUDID (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Circassia AB's devices fall under?
Among its 25 most recently registered devices, the classes recorded for Circassia AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Circassia AB in the registry?
The most recently registered devices listed for Circassia AB include NIOX VERO Battery, NIOX VERO Test Kit 300, NIOX MINO Sensor 50 and NIOX VERO Filter.