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Qualisys AB

US

Last updated May 30, 2026

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. Qualisys AB is based in the US. The company's devices must comply with relevant regulatory requirements to be marketed and used in clinical settings.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of devices does Qualisys AB manufacture?

Qualisys AB makes gait analysis systems, such as the Qualisys Clinical System, which are used to analyze a person's walking patterns, because the company's primary focus is on designing devices for clinical gait analysis.

Where is Qualisys AB based?

Qualisys AB is based in the US, as indicated by the company's country of origin.

Which registries list Qualisys AB's devices?

Qualisys AB's devices are listed in the FDA's 510(k) and UDI registries, because these registries track medical devices that have been cleared for marketing in the US.

How are Qualisys AB's devices classified?

Qualisys AB's devices are classified as Class II devices, which means they are subject to regulatory requirements and guidelines that ensure their safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
qualisys.com
LinkedIn
—
Facebook
—
Phone
2246369833
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
632151952

Catalogue (2)

DeviceModel / ReferenceRegistriesClassStatus
Qualisys Clinical System 1.5.0.408
FDA UDI
Class IIActive
Qualisys Clinical System K171547
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Qualisys Ab Goteborg Vastra Gotaland · SE FEI 3015786441