cNeuro cDSI

by Combinostics Oy

Ref cNeuro cDSI

Active European Union

CE MDR CE MDD

Valid until

19 Feb 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	NumberFI22/871878	Date10 Oct 2025Issued	StatusActive expires 19 Feb 2030
European Union	CE/MDD	Number6430070842027N Basic UDI-DI 06430070842028UDI-DI	Date14 Jun 2022Registered	StatusActive
European Union	CE/MDR	Number6430070842027N Basic UDI-DI 06430070842028UDI-DI	Date14 Jun 2022Registered	StatusActive

Certificates

1 certificate · EUDAMED

FI22/871878 Active Supplemented

Quality management system EU MDR

Certifier

SGS FIMKO OY 0598

Issued
10 Oct 2025

Expires
19 Feb 2030

Valid from
11 Oct 2025

Reason
Change approved

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device Name: cNeuro cDSI
Model / Reference: cNeuro cDSI

Primary DI / UDI-DI: 06430070842028
Basic UDI-DI: 6430070842027N, B-06430070842028
EMDN Code: V92 Medical device software - not included in other classes

Device Class: Class IIa
Special Device Type: Software
-1192
EU market of registration: Finland

Manufacturer details

EUDAMED SRN: FI-MF-000011968

Other devices from Combinostics Oy

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Class IIa
cNeuro cPET

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cNeuro cDAT

Class IIa

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No