EU → North America Device Access

EB Neuro S.p.A.

IT-MF-000027944 · Italy · FIRENZE

EB Neuro S.p.A. is registered in the European database on medical devices as a manufacturer, with 221 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa206
Class IIb15

Most frequent device types declared: Ear lobe reference electrode, Elettrodi ad ago monopolare monouso Ø0.40x13mm con cavo L=100cm (4x5 c.

Among these devices, 1 are declared sterile, 15 active, 1 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 221 declared devices.

Catalogue references include B9602094534, B9602094536, B9602094913, B9642094004, B9720104032, B9720320902.

European nomenclature codes declared: N01010203, N01010299, N01010202, N010180, C020501, N010101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryEB NEURO S.P.A. (IT) · FDA 3001687738
Devices in EUDAMED221
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN221
Found in the U.S. device database14
Share6.3 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryEBNEURO S.P.A.

North American profile: Both markets. EB Neuro S.p.A. is registered in both the United States and Canada.

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