Data / Medical devices / Sweden / Qualisys AB

Qualisys AB: FDA-registered device maker in Goteborg Vastra Gotaland, Sweden, 1 510(k) clearance

Qualisys AB is registered with the FDA (registration 3015786441) in Goteborg Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3015786441

Address

Kvarnbergsgatan 2, Goteborg Vastra Gotaland, Sweden, 411 05

Owner or operator

Qualisys AB (10061206)

Roles

Manufacturer

First device listed

September 16, 2019

Registered through

2026

Brand names listed

Qualisys Clinical System (QCS)

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

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Updated August 2, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.