Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001687738

FEI Number

3001687738

Entity Name

EB NEURO S.P.A.

City/State/Country

Arbizzano di Valpolicella Verona, IT

Establishment Address

Via Bologna 1, Arbizzano di Valpolicella Verona 37020, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EB NEURO, S.P.A. (Owner Number: 9043444)

Owner / Operator Contact Address

VIA PIETRO FANFANI 97/A, --, FLORENCE, IT-NOTA 50127, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121996

PMA Number

N/A

All Registered Proprietary Names

NExT Station Advanced NExT Station Galileo NT NEMUS PC NEMUS STM9000 STM9000 ULTRA-FAST_BI STM9000 BASIC STM9000 STANDARD STM9000 FAST STM9000 STANDARD_BI STM9000 ULTRA-FAST STM9000 FAST_BI BE Plus LTM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-04-22
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2025-04-22
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-04-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-04-22
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2025-04-22
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2025-04-22
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2016-03-03
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2016-03-03
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2016-03-03
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2016-03-03
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2016-03-03
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2016-03-03
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2016-03-03
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2016-03-03
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2009-04-01
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2009-04-01
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2009-04-01
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2009-04-01
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-09-08
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2012-12-07

Official Correspondent

Christiano Pineider

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

EB NEURO, S.P.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9617286	EB NEURO, S.P.A.	FLORENCE Tuscany, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001687738. Last updated year: 2026. Please use registration number 3001687738 when referencing this establishment in official correspondence.