BIOSERENITY

Address:47 BOULEVARD DE L HOPITAL,PARIS CEDEX 13 Ile-de-France,FR

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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

Medical Device Data System (OUG) (2) Electrode, Cutaneous (GXY) (1) Full-Montage Standard Electroencephalograph (GWQ) (1)

Premarket Exempt

No Yes

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Neuronaute IceCap - 03615220001521 Catalog Number : 1001-01010-US

Device Description : The Neuronaute IceCap is intended to acquire, display, store, and archive EEG si The Neuronaute IceCap is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.

Device Class : 2

Duns Number: 265828238

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Neuronaute 1.2 - Head module - 03615220001774 Catalog Number : 1001-10004-US

Device Description : Neuronaute Head Module is intended to acquire, display, store, and archive EEG s Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.

Device Class : 2

Duns Number: 265828238

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Bioserenity Cloud - 03615220002573 Catalog Number : 1012-21002-US

Device Class : 1

Duns Number: 265828238

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Neuronaute Application Mobile iOS - 03615220002610 Catalog Number : 5100-00012

Device Class : 1

Duns Number: 265828238

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

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