ENOBIO

GUDID 00084637017440

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.

NEUROELECTRICS BARCELONA SL

Electroencephalographic monitoring system, portable

• Primary Device ID: 00084637017440
• NIH Device Record Key: ab460f7d-0e13-4410-93a6-e4821c3dc261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENOBIO
• Version Model Number: WF
• Company DUNS: 463756944
• Company Name: NEUROELECTRICS BARCELONA SL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +16176820770
• Email: ana.maiques@neuroelectrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00084637017440 [Primary]

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-01
• Device Publish Date: 2019-06-21

On-Brand Devices [ENOBIO]

• 00084637017440: Enobio is a Wireless EEG, performs electroencephalographic measures with non-invasive technology
• 08437017440796: Enobio is a Wireless EEG, performs electroencephalographic measures with non-invasive technology