EU → North America Device Access

Neuromod Devices Limited

IE-MF-000004261 · Ireland · Dublin

Neuromod Devices Limited is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: SM-301, TP-101.

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include EU1, EU2, EU3.

European nomenclature codes declared: Z12149099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNEUROMOD DEVICES LIMITED (IE) · FDA 3018030059
Devices in EUDAMED6
Country of registrationIreland

Device-level evidence

Devices with a numeric GTIN6
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryNEUROMOD DEVICES LTD.

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2025-07-15

Licence types: System (1).

Licensed under: LENIRE.

North American profile: Both markets. Neuromod Devices Limited is registered in both the United States and Canada.

Other manufacturers in Ireland

All Ireland manufacturers →