FDA.reportPublic FDA data

eego amplifier

Primary DI
B195EE225
Brand
eego amplifier
Company
eemagine Medical Imaging Solutions GmbH
Model
EE-225
Device description
physiological signal amplfier
Published
2025-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAMPLIFIER, PHYSIOLOGICAL SIGNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172312000eego amplifiersEemagine Medical Imaging Solutions GmbH2018-03-30GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B195EE225PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic signal amplifierAn electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+493029048404support@eemagine.com

Regulatory Flags#

DUNS number
313152485
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B195XC813waveguardXC-8132026-03-19
B195CA520waveguardCA-5202025-12-16
B195CA521waveguardCA-5212025-12-16
B195CA522waveguardCA-5222025-12-16
B195NA215waveguardNA-2152025-12-16
B195NA276waveguardNA-2762025-12-16
B195NA415waveguardNA-4152025-12-16
B195XC315waveguardXC-3152025-12-16
B195XS268waveguardXS-2682025-12-16
B195XS269waveguardXS-2692025-12-16
B195XS272waveguardXS-2722025-12-16
B195XS297waveguardXS-2972025-12-16
B195EE223eego amplifierEE-2232025-09-29
B195LC100cognitraceLC-1002021-07-27
B195LC104cognitraceLC-1042020-04-30
B195LC105cognitraceLC-1052020-04-30
B195LC106cognitraceLC-1062020-04-30
B195LC107cognitraceLC-1072020-04-30
B195SC100cognitraceSC-1002020-04-30
B195ES220eegoES-2202020-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009903715Quick-20mCGX, LLCGWL2025-09-29
B195EE223eego amplifiereemagine Medical Imaging Solutions GmbHGWL2025-09-29
00817111021332PolysmithNeurotronics, LLCGWL2025-09-23
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWL2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWL2025-05-22
08056446901113NExT-PADEB NEURO SPAGWL2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWL2025-05-22
08056446901137NExT-HSEB NEURO SPAGWL2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWL2025-05-22
08056446901199NExT-ASEB NEURO SPAGWL2025-05-22
08056446901205NExT StationEB NEURO SPAGWL2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWL2025-05-19
00814901021541Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
00814901021558Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
08056446900673Neurotravel LIGHTEB NEURO SPAGWL2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWL2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWL2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWL2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWL2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWL2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWL2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWL2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWL2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWL2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWL2024-12-04
EBCI5730PRO0g.Nautilus PROg.tec medical engineering GmbHGWL2024-05-28
00814901021527Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2023-12-04
00814901021534Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2023-12-04