EU → North America Device Access

Neuroelectrics Barcelona, S.L.U.

ES-MF-000033432 · Spain · Barcelona

Neuroelectrics Barcelona, S.L.U. is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa28

Most frequent device types declared: Electrodes - EEG, Electrodes - EEG + tES, Electrodes - tES, Enobio 20, Enobio 32.

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include NE003WF.G.MD:EU / NE003WF.S.MD:EU, NE006WF.G.MD:EU / NE006WF.S.MD:EU, NE019-P-NB1.0K.WH.MD:GV, NE019-P-NB1.KS.WH.MD:GV, NE020-P, NE021-P.08.MD:GV.

European nomenclature codes declared: Z12101102, N01010202, Z12100302, Z12100380, N01010202,Z12101185, Z12101185.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNEUROELECTRICS BARCELONA S.L.U. (ES) · FDA 3010762896
Devices in EUDAMED28
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN28
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryNEUROELECTRICS BARCELONA S.L.U.

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2012-12-17

Licence types: Device Family (1).

Licensed under: ENOBIO.

North American profile: Both markets. Neuroelectrics Barcelona, S.L.U. is registered in both the United States and Canada.

Other manufacturers in Spain

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