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Data / Medical devices / Sweden / Scibase AB

Scibase AB: FDA-registered device maker in sundbyberg Stockholm, Sweden, 1 PMA approval

Scibase AB is registered with the FDA (registration 3008285458) in sundbyberg Stockholm, Sweden. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated June 28, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3008285458
Address
Landsvagen 39, sundbyberg Stockholm, Sweden, 17263
Owner or operator
Scibase AB (10055319)
Roles
Manufacturer
First device listed
July 6, 2017
Registered through
2026
Brand names listed
Nevisense, SalveQuick Saline Wipes

Devices it lists

DeviceProduct codeClassRoleSource
Electrical Impedance SpectrometerONV2Manufactureraccessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
June 28, 2017P150046NEVISENSEONV6February 26, 2026accessdata.fda.gov

Updated February 26, 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.