NE003WF.G.MD:EU / NE003WF.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

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

  EUDAMED did not publish a description for this code.
• CW274

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  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

18436612820207

Basic UDI-DI

B-18436612820207

Reference / catalog number

NE003WF.G.MD:EU / NE003WF.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 8 are EEG portable monitoring devices of 8 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