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Data / Medical devices / Ireland / Neuromod Devices Limited

Neuromod Devices Limited: FDA-registered device maker in Dublin Dublin(City), Ireland, 1 510(k) clearance

Neuromod Devices Limited is registered with the FDA (registration 3018030059) in Dublin Dublin(City), Ireland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 6, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3018030059
Address
Rainsford Street, Dublin Dublin(City), Ireland, D08 R2YP
Owner or operator
Neuromod Devices Limited (10087563)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
March 15, 2023
Registered through
2026
Brand names listed
Lenire

Devices it lists

DeviceProduct codeClassRoleSource
Combined Acoustic And Electrical External Stimulation Device For The Relief Of TinnitusQVN2Complaint file establishment, Repackager or relabeler, Specification 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
March 6, 2023DEN210033Lenire Tinnitus Treatment DeviceQVNUnknownNeuromod Devices Limitedaccessdata.fda.gov

Updated March 6, 2023. 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.