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cNeuro cMRI

by Combinostics Oy

Ref cNeuro cMRI

Active Active in United States. Withdrawn in European Union.

CE MDR, withdrawn CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier SGS FIMKO OY

510(k) K171328↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberFI22/871878 Date10 Oct 2025IssuedStatusWithdrawn No longer placed on the EU market expires 19 Feb 2030
European UnionCE/MDD EUDAMED NumberB-06430070840017 Basic UDI-DI 06430070840017UDI-DIDate2 Mar 2022RegisteredStatusWithdrawn No longer placed on the EU market
United StatesFDA 510(k) 510(k) NumberK171328 Date8 Jan 2018IssuedStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name
cNeuro cMRI
Model / Reference
cNeuro cMRI
Primary DI / UDI-DI
06430070840017
Basic UDI-DI
B-06430070840017, 6430070841027H
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
-1192
Software
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000011968

Other devices from Combinostics Oy

  • cNeuro cMRI

    Class IIa

  • cNeuro cPET

    Class II

  • cNeuro cDAT

    Class IIa

  • cNeuro cDSI

    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