Data / Medical devices / Italy / Eb Neuro S.P.A.

Eb Neuro S.P.A.: FDA-registered device maker in Arbizzano di Valpolicella Verona, Italy, 6 510(k) clearances

Name: Eb Neuro S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Eb Neuro S.P.A. is registered with the FDA (registration 3001687738) in Arbizzano di Valpolicella Verona, Italy. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3001687738
Address: Via Bologna 1, Arbizzano di Valpolicella Verona, Italy, 37020
Owner or operator: EB NEURO, S.P.A. (9043444)
Roles: Manufacturer
First device listed: April 1, 2009
Registered through: 2026
Brand names listed: BE Plus LTM, Galileo NT, NEMUS, NEMUS PC, NExT Station, NExT Station Advanced, Nemus 2 System, STM9000 and more

Devices it lists

Device	Product code	Class	Role	Source
Amplifier, Physiological Signal	GWL	2	Manufacturer	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 12, 2024	K242832	NExT Station; NExT Station Advanced	GWL	Substantially Equivalent	Eb Neuro S.P.A.	accessdata.fda.gov
August 19, 2015	K150220	STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast	GWF	Substantially Equivalent	Eb Neuro S.P.A.	accessdata.fda.gov
February 13, 2015	K142064	GALILEO NT	OLT	Substantially Equivalent	Eb Neuro S.P.A.	accessdata.fda.gov
February 26, 2014	K133517	NEMUS 2 SYSTEM	GWL	Substantially Equivalent	Eb Neuro S.P.A.	accessdata.fda.gov
August 3, 2012	K121996	BE PLUS LTM AMPLIFIER GWI AMPLIFIER	GWL	Substantially Equivalent	Eb Neuro S.P.A.	accessdata.fda.gov
May 23, 2008	K073415	NEMUS SYSTEM; NEMUS PC PERIPHERAL	IKN	Substantially Equivalent	Eb Neuro S.P.A.	accessdata.fda.gov

Compare with other makers

Updated December 12, 2024. 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.