HOLBERG EEG AS

FDA Device Registration & Listing · Bergen Hordaland, NO · Registration 3030646118

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030646118
FEI Number
3030646118
Entity Name
HOLBERG EEG AS
City/State/Country
Bergen Hordaland, NO
Establishment Address
Fjosangerveien 70 A, 5068 Bergen, Bergen Hordaland 5068, NO
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Holberg EEG AS (Owner Number: 10090411)
Owner / Operator Contact Address
Fjosangerveien 70 A, 5068 Bergen, Bergen, NO-NOTA 5068, NO
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231068
PMA Number
N/A

All Registered Proprietary Names

autoSCORE (V 2) autoSCORE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2025-06-17
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2024-03-25

Official Correspondent

Smriti Franklin

US Agent Details

Courtney Walton Business: Natus Neuro Email: Courtney.Walton@natus.com Phone: (651) 4215870

Related Public Records

Same Entity

Holberg EEG AS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030646118. Last updated year: 2026. Please use registration number 3030646118 when referencing this establishment in official correspondence.
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