Qualisys AB
SwedenFDA applicant, unverified FDA FEI 3015786441
Qualisys AB is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 13 Nov 2026.
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 1
- FDA GUDID 1
- Device classes
- FDA Class II 2
- Identifiers
- FDA FEI 3015786441
- DUNS 632151952
At a glance
Market reach
- United States
- FDA FEI
What Qualisys AB makes
Qualisys AB makes gait analysis systems, including the Qualisys Clinical System, which is a type of device used to analyze a person's gait. These systems are designed to provide detailed information about an individual's walking patterns. The company's products are used in clinical settings to assess and treat various conditions.
The company's portfolio is regulated as Class II devices and is listed in the FDA's 510(k) and UDI registries. The company's devices must comply with relevant regulatory requirements to be marketed and used in clinical settings.
Catalogue
- Regimes: 510(k) Registry: GUDID
Qualisys Clinical System Ref K171547
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3015786441
- DUNS number
- 632151952
- Address
- Kvarnbergsgatan 2, Goteborg Vastra Gotaland
- support@qualisys.com
- Phone
- 2246369833
Frequently asked questions
How many devices does Qualisys AB have in the registry?
The registry currently lists 2 devices for Qualisys AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qualisys AB's devices?
Among its 2 most recently registered devices, Qualisys AB has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Qualisys AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Qualisys AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qualisys AB in the registry?
The most recently registered devices listed for Qualisys AB include Qualisys Clinical System 1.5.0.408 and Qualisys Clinical System.