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Data / Medical devices / Netherlands / Livassured

Livassured: FDA-registered device maker in Leiden Zuid-Holland, Netherlands, 1 510(k) clearance

Livassured is registered with the FDA (registration 3017084392) in Leiden Zuid-Holland, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3017084392
Address
Schipholweg 103, Leiden Zuid-Holland, Netherlands, 2316 XC
Owner or operator
Livassured (10094699)
Roles
Specification developer
First device listed
December 17, 2025
Registered through
2026
Brand names listed
NightWatch+ US

Devices it lists

DeviceProduct codeClassRoleSource
Physiological Signal Based Seizure Monitoring SystemPOS2Specification developeraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 12, 2025K243199NightWatch+ USPOSSubstantially EquivalentLivassured BVaccessdata.fda.gov

Compare with other makers

Updated July 12, 2025. 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.