Cerenion Oy

Certificate FI23/00000060

Rev. Issue 4Reissued

Valid until: May 4, 2030

Certificate FI23/00000060 is a valid Quality management system issued to Cerenion Oy and registered in EUDAMED. Valid until May 4, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FI23/00000060
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI23/00000060Issue 4

Validity

Issued: May 4, 2026
Valid from: May 5, 2026
Valid until: May 4, 2030

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Supersedes

FI23/00000060Quality management systemSupplementedDec 8, 2025 → Dec 27, 2027

Scope coverage

Class IIb3

3 scopes

Medical device software, Z12100392 Electroencephalography instruments.
Class IIb
Cerenion C-Trend Software Library, v1.1 * Basic UDI-DI: 642981101130010092
Class IIb
C-Trend EEG Software, v1.0 * Basic UDI-DI: 642981101130020097
Class IIb

Documents

LanguagesEN