Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010762896

FEI Number

3010762896

Entity Name

NEUROELECTRICS BARCELONA S.L.U.

City/State/Country

Barcelona Catalonia, ES

Establishment Address

Av Tibidabo, 47 Bis, Barcelona Catalonia 08035, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Neuroelectrics Barcelona, S.L.U. (Owner Number: 10055170)

Owner / Operator Contact Address

Av Tibidabo, 47 Bis, Barcelona, ES-CT 08035, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162681

PMA Number

N/A

All Registered Proprietary Names

Enobio Dx 8 Enobio Dx 20 Enobio Dx 32

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-06-15
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2017-06-15

Official Correspondent

Conxi Verdu

US Agent Details

Ana Maiques Business: Neuroelectrics USA Corporation Email: qa@neuroelectrics.com Phone: (617) 6820770

Related Public Records

Same Entity

Neuroelectrics Barcelona, S.L.U.

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

View Entity Profile →

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.

Similar Registrations

Registration Number	Establishment Name	Location
3005733633	EPM GLOBAL SERVICES INC., DBA VEXOS	Markham Ontario, CA
3013413442	CO-AX TECHNOLOGY, INC.	Solon, OH, US
3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
8020045	LEONHARD LANG GMBH	INNSBRUCK Tirol, AT
2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010762896. Last updated year: 2026. Please use registration number 3010762896 when referencing this establishment in official correspondence.