Galileo NT Line Software

GUDID 08056446900642

Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.

EB NEURO SPA

Bioelectrical signal analysis software

• Primary Device ID: 08056446900642
• NIH Device Record Key: bdd6ca75-8c5a-445f-adda-22b303974d93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galileo NT Line Software
• Version Model Number: B8640053000
• Company DUNS: 339182263
• Company Name: EB NEURO SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056446900642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142064

FDA Product Code

• JXE: Device, Nerve Conduction Velocity Measurement

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: 2020-06-02
• Device Publish Date: 2020-05-25

Devices Manufactured by EB NEURO SPA

• 08056446900185 - USB FLASH ADAPTER CABLE L=3m: 2024-12-12 Flash Stimulator Interface
• 08056446900192 - USB FLASH ADAPTER CABLE L=5m: 2024-12-12 Flash Stimulator Interface
• 08056446900673 - Neurotravel LIGHT: 2024-12-12 Neurotravel LIGHT is an active medical device aimed to collect and record physiological signals from human body. It includes amp
• 08056446900680 - Neurotravel LIGHT Base Unit: 2024-12-12 Acquisition unit
• 08056446900895 - BE PLUS PRO LIGHT: 2024-12-12 Acquisition unit
• 08056446900901 - BE PLUS PRO STANDARD: 2024-12-12 Acquisition unit
• 08056446900918 - BE PLUS PRO FULL: 2024-12-12 Acquisition unit
• 08056446900925 - BE PLUS PRO ADVANCED: 2024-12-12 Acquisition unit