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Cerenion Oy

Finland FI-MF-000012993 Last updated 21 Oct 2026

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Devices
4
Registries
EUDAMED
FDA recalls
0

Catalogue4

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

SGS FIMKO OY 0598 2 certificates

  • FI23/00000060 Reissued

    Quality management system EU MDR

    Issued
    4 May 2026
    Expires
    4 May 2030
    Valid from
    5 May 2026
  • FI23/00000060 Supplemented

    Quality management system EU MDR

    Issued
    8 Dec 2025
    Expires
    27 Dec 2027
    Valid from
    9 Dec 2025
    Reason
    Add device or group

Notified bodies

About

Explore Cerenion's C-Trend® brain monitoring solution for intensive care, simplifying EEG readings for better bedside care. Read more

From the manufacturer's own website. Source

What Cerenion Oy makes

Cerenion Oy produces software and hardware for electroencephalogram (EEG) monitoring in intensive care settings, including EEG analysis software, disposable electrodes, and a software library for managing EEG data. The C-Trend platform is designed to facilitate real-time EEG signal processing and interpretation at the bedside, aiding clinical decision-making.

The company’s EEG-related devices are classified under Class I and Class IIb in the EU, with relevant products registered in the EUDAMED database. Cerenion Oy is headquartered in Finland and adheres to EU regulatory requirements for medical device compliance.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Cerenion Oy manufacture?

Cerenion Oy develops medical devices primarily focused on electroencephalogram (EEG) monitoring for intensive care. Their portfolio includes software solutions like the C-Trend EEG Software and Cerenion C-Trend Software Library, as well as disposable hardware such as the C-Trend EEG Electrode. These devices are designed to simplify EEG readings and improve bedside care by enabling real-time signal processing and analysis.

Where is Cerenion Oy based, and what regulatory requirements do they follow?

Cerenion Oy is headquartered in Finland. Their devices are developed in compliance with EU regulatory standards, ensuring they meet the necessary requirements for medical device safety, performance, and traceability. Since their products are classified under EU medical device regulations, they are registered in the EUDAMED database, which is the official EU registry for medical devices.

Which EU medical device classes apply to Cerenion Oy’s products?

Cerenion Oy’s EEG-related devices are classified under both Class I and Class IIb in the EU regulatory framework. The classification depends on factors like the intended use, risk associated with the device, and its interaction with patients. For example, disposable electrodes like the C-Trend EEG Electrode may fall under Class I due to lower risk, while software solutions like the C-Trend EEG Software could be classified as Class IIb due to higher clinical decision-making implications.

Are Cerenion Oy’s devices listed in any regulatory registries?

Yes, Cerenion Oy’s medical devices are registered in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices placed on the EU market, allowing healthcare professionals, regulators, and other stakeholders to verify the compliance and details of the company’s products.

How are Cerenion Oy’s devices used in clinical settings?

Cerenion Oy’s devices, such as the C-Trend platform, are designed for intensive care environments where continuous EEG monitoring is critical. The C-Trend EEG Software processes real-time brainwave data, while disposable electrodes like the C-Trend EEG Electrode enable accurate signal capture. Together, these tools help clinicians interpret EEG readings more efficiently at the bedside, supporting timely clinical decisions in high-risk patient care scenarios.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Finland
Address
3, Elektroniikkatie, Oulu, Finland
Website
cerenion.com/
Phone
+358 50 447 4909(from company website)
PRRC contact
Sanna Hosio
EUDAMED SRN
FI-MF-000012993