NEUROELECTRICS BARCELONA SL

Address:Av Tibidabo, 47 Bis,Barcelona Catalonia,ES

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Amplifier, Physiological Signal (GWL) (1) Full-Montage Standard Electroencephalograph (GWQ) (1)

Premarket Exempt

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ENOBIO - 08437017440796 Catalog Number :

Device Description : Enobio is a Wireless EEG, performs electroencephalographic measures with non-inv 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.

Device Class : 2

Duns Number: 463756944

Premarket Exempt : No

Product Code : GWQ, GWL

Prescription Use : Yes

Device Count : 1

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