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Data / Medical devices / Sweden / Flow Neuroscience AB

Flow Neuroscience AB: FDA-registered device maker in Malmo Skane, Sweden, 1 PMA approval

Flow Neuroscience AB is registered with the FDA (registration 3045752358) in Malmo Skane, Sweden. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated December 8, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3045752358
Address
Sodra Tullgatan 3, Malmo Skane, Sweden, 211 40
Owner or operator
Flow Neuroscience AB (10095959)
Roles
Manufacturer
First device listed
May 29, 2026
Registered through
2026
Brand names listed
Flow FL-100

Devices it lists

DeviceProduct codeClassRoleSource
Cranial Electrotherapy Stimulator To Treat DepressionJXK3Manufactureraccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
December 8, 2025P230024Flow FL-100JXK1July 14, 2026accessdata.fda.gov

Compare with other makers

Updated July 14, 2026. 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.