ENOBIO

Primary DI
00084637017440
Brand
ENOBIO
Company
NEUROELECTRICS BARCELONA SL
Model
WF
Device description
Enobio is a Wireless EEG, performs electroencephalographic measures with non-invasive technology. Enobio is a Wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording.
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00084637017440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00084637017440000846370174400846370174400084637017440

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring system, portableA mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is designed to be easily moved and is commonly used at the patient's bedside, in an intensive care unit (ICU), or an examination room.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16176820770ana.maiques@neuroelectrics.com

Regulatory Flags#

DUNS number
463756944
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18436612824038Enobio DxTouchproof Adapter 8 - Component Spare Part: Enobi2026-09-18
18436612824045Enobio DxTouchproof Adapter 20 - Component Spare Part: Enob2026-09-18
18436612824052Enobio DxTouchproof Adapter 32 - Component Spare Part: Enob2026-09-18
18437017440601Enobio DxDrytrode - Component Spare Part: Enobio Dx2023-09-14
18437017440632Enobio DxForetrode - Component Spare Part: Enobio Dx2023-09-14
18437017440663Enobio DxNG Geltrode - Component Spare Part: Enobio Dx2023-09-14
18437017440687Enobio DxNG Pistim - Component Spare Part: Enobio Dx2023-09-14
18436612823031Enobio DxNeoprene Headcap (size L) - Component Spare Part: 2023-09-14
18436612823048Enobio DxNeoprene Headcap (size M) - Component Spare Part: 2023-09-14
18436612823055Enobio DxNeoprene Headcap (size S) - Component Spare Part: 2023-09-14
18436612823062Enobio DxNeoprene Headcap (size XL) - Component Spare Part:2023-09-14
18436612823079Enobio DxNeoprene Headband - Component Spare Part: Enobio D2023-09-14
08437017440390Enobio DxDrytrode - Component Spare Part: Enobio Dx2023-09-14
18437017440618Enobio DxEarclip - Component Replacement: Enobio Dx2023-09-14
18437017440625Enobio DxForetrode - Component Replacement: Enobio Dx2023-09-14
08437017440383Enobio DxForetrode - Component Spare Part: Enobio Dx2023-09-14
18437017440656Enobio DxNG Geltrode - Component Replacement: Enobio Dx2023-09-14
08437017440376Enobio DxNG Geltrode - Component Spare Part: Enobio Dx2023-09-14
18437017440670Enobio DxNG Pistim - Component Replacement: Enobio Dx2023-09-14
08437017440406Enobio DxNG Pistim - Component Spare Part: Enobio Dx2023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824045Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
B592SW100WAVi Scan SoftwareWAVI CO.GWQ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWQ2026-03-25
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08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
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08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWQ2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
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18437017440601Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440632Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440663Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440687Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
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