Holberg EEG AS

Certificate C685394

Rev. 0Issued

Valid until: Aug 22, 2030

Certificate C685394 is a valid Quality management system issued to Holberg EEG AS and registered in EUDAMED. Valid until August 22, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C685394
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C6853940

Validity

Issued: Aug 22, 2025
Valid from: Aug 22, 2025
Valid until: Aug 22, 2030

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Software-only decision support product intended to be used with compatible EEG software
Class IIa
autoSCORE
Class IIa

Documents

LanguagesEN