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cNeuro cMRI

by SyntheticMR AB Sweden EUDAMED

Ref 0

EMDN Z11050192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number28620110677-01 Date8 Jun 2026IssuedStatusActive expires 30 Sep 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
0
Primary DI / UDI-DI
07340024710008
Basic UDI-DI
73400247S02QR
Direct Marketing DI
07340024710008
EMDN Code
Z11050192 Magnetic resonance (mr) systems - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
SE-MF-000003513

Other devices from SyntheticMR AB

  • SyMRI 15

    Class IIa

  • SyMRI 12

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED da49ae78-9bdc-4503-81ba-b59effa774bb 61 fields · synced 22 Oct 2026