Autoscore AS001 V2

GUDID 05060941990018

Autoscore

Holberg Eeg AS

Electroencephalographic diagnosis-support software

• Primary Device ID: 05060941990018
• NIH Device Record Key: a4b624cb-a863-41e7-87a0-def18461783f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autoscore
• Version Model Number: AS001 V2
• Catalog Number: AS001 V2
• Company DUNS: 671267551
• Company Name: Holberg Eeg AS
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060941990018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243743

FDA Product Code

• OMB: Automatic Event Detection Software For Full-Montage 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: 2026-02-05
• Device Publish Date: 2026-01-28