FDA.reportPublic FDA data

BE PLUS PRO [ADVANCED]

Primary DI
08056446901342
Brand
BE PLUS PRO [ADVANCED]
Company
EB NEURO SPA
Model
B9800078004
Device description
BE PLUS PRO [ADVANCED] is an active medical device aimed to collect and record physiological signals from human body.It includes amplifier and accessories.
Published
2024-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal
GWQFull-Montage Standard Electroencephalograph
OLTNon-Normalizing Quantitative Electroencephalograph Software
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242305000BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.2024-09-04GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056446901342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056446901342080564469013428056446901342

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390554565111info@ebneuro.com

Regulatory Flags#

DUNS number
339182263
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056446900338NeMus 2 600B98000666012025-05-26
08056446900345NeMus 2 700B98000667012025-05-26
08056446900352NeMus 2 +B98000668012025-05-26
08056446901038GOGGLES STIMULATOR IIB97000910002025-05-22
08056446901106NExT-DOCKINGB97000960002025-05-22
08056446901113NExT-PADB97000960102025-05-22
08056446901120NExT-AMP-ADVANCEDB96300960052025-05-22
08056446901137NExT-HSB97001080002025-05-22
08056446901168NExT-AMPB96300960022025-05-22
08056446901199NExT-ASB91090001412025-05-22
08056446901205NExT StationB98000960012025-05-22
08056446901090NExT Station AdvancedB98000960002025-05-19
08056446900642Galileo NT Line SoftwareB86400530002020-05-25
08056446900659Isolation Transformer ‘GP’ 110-120 VAC 50/60 HzB97000410012019-05-24
08056446900178Flash Led StimulatorB97000630002019-04-10
08056446900185USB FLASH ADAPTER CABLE L=3mB91006308002024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mB91006308102024-12-04
08056446900673Neurotravel LIGHTB98001020002024-12-04
08056446900680Neurotravel LIGHT Base UnitB97001020002024-12-04
08056446900895BE PLUS PRO LIGHTB97000780012024-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15
08720256698524Onera STSOnera B.V.OLV2026-05-15
08720256698531Onera STSOnera B.V.OLV2026-05-15
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWL2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWL2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAGWL2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWL2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAGWL2025-05-22