12 results
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108ms
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Sources: EU EUDAMED, US FDA
NEUROWAVE SYSTEMS, INC.
Manufacturer
🇺🇸 United States
NEUROWAVE SYSTEMS, INC.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.
NeuroSENSE Monitoring System, Model NS-901, with EasyPrep Electrodes EK-901
FDA registration
NEUROWAVE SYSTEMS INC.·5 products·🇺🇸 United States
EEG HOLTER SYSTEMS
Device
EU MDD
·
Eu Md Class 2b
·NEUROWAVE SYSTEMS, INC.·On the market·32 countries
EasyPrep Sensor Kit
FDA UDI
Neurowave Systems Inc.·B746EK9011·
NeuroSENSE
FDA UDI
Neurowave Systems Inc.·B746NS90101·
NeuroSENSE Monitoring System, Model NS-901
FDA 510(k)
FDA Class 2
·Neurology
DiscoverEEG System, Model DE-401
FDA 510(k)
FDA Class 2
·Neurology
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
FDA 510(k)
FDA Class 2
·Neurology
NeuroSENSE Monitoring System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·NEUROWAVE SYSTEMS, INC.·1 device
CE 545606
Certificate
MDD Annex II (excluding section 4)·NEUROWAVE SYSTEMS, INC.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
AF Pharma Service Europe SL
Authorized representative
🇪🇸 Spain·51 Manufacturers·881 Devices