NE006WF.G.MD:EU / NE006WF.S.MD:EU

Organization name

Neuroelectrics Barcelona, S.L.U.

SRN

ES-MF-000033432

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• CW007

  EUDAMED did not publish a description for this code.
• CW014

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• CW274

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• CW011

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• CW010

  EUDAMED did not publish a description for this code.
• CW027

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 28 countries total.

Trade name

not provided

UDI-DI code

18436612820221

Basic UDI-DI

B-18436612820221

Reference / catalog number

NE006WF.G.MD:EU / NE006WF.S.MD:EU

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Enobio are wireless, battery‑operated and portable electrophysiology sensor systems for the recording of the electroencephalogram (EEG). Enobio 32 are EEG portable monitoring devices of 32 channels intended for the diagnosis and monitoring of brain diseases in both adult and children patients.

Additional information URL

https://www.neuroelectrics.com/ifu

Clinical sizes

No clinical sizes registered for this device.

• Z12100302ELECTROENCEPHALOGRAPHS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification