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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Neurology and neurosurgery instruments
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Electroencephalography instruments
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Electroencephalographs
Electroencephalographs
Z12100302
132 devices
Dx Braintest Plus
Limited Liability Company Research and Production Enterprise DХ-SYSTEMS
·
,
Ukraine
Class IIa
CE/MDD
SynAmps2/RT
Compumedics Limited
·
,
Australia
Class IIa
CE/MDD
GUDID
on market
Quantum II, Main Breakout Assembly
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
Natus Brain Monitor and Embla Dx
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
8-CH Electroencephalography Amplifier
HippoScreen Neurotech Corp
·
,
Taiwan
Class IIa
FDA 510(k)
K201747
Active
Cleared 27 Dec 2020
CE/MDR
Bc-1
BrainCapture ApS
·
,
Denmark
Class IIa
CE/MDR
NARCOguide, Cardio-Version
SOMNOmedics AG
·
,
Germany
Class IIb
CE/MDR
Natus Brain Monitor and Embla Dx
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
eego amplifier
Eemagine Medical Imaging Solutions GmbH
·
,
Germany
Class IIa
CE/MDR
Grael
Compumedics Limited
·
,
Australia
Class IIa
CE/MDD
Neuron-Spectrum-64
Neuromed
·
,
France
Class IIa
CE/MDR
Natus Quantum
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Natus Quantum
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Evidence EEG65
Neuromed
·
,
France
Class IIa
CE/MDR
Disposable EEG sensor
Braincare (Beijing) medical device co. LTD
·
,
China
Class I
CE/MDR
ExcMT-EEG-F
NCCMedical Pte Ltd
·
,
Singapore
Class IIa
CE/MDR
Neuromonitor
Neuromed
·
,
France
Class IIa
CE/MDR
32-channel EEG headbox for SOMNO HD with a longer cable
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Lemo Patient call cord 2’
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class I
CE/MDR
GUDID
on market
DeltaScan Monitor
Prolira BV
·
,
Netherlands
Class IIa
FDA 510(k)
K222680
Active
Cleared 2 Feb 2023
CE/MDR
+1
authorizations
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