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Core Cognitive Evaluation

by Linus Health United States EUDAMED

Ref 20006

EMDN Z12109092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B626CCEPE Basic UDI-DIDate4 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Core Cognitive Evaluation
Model / Reference
20006
Primary DI / UDI-DI
*+B626200060
Basic UDI-DI
++B626CCEPE
EMDN Code
Z12109092 Various neurology and neurosurgery instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000024342
Authorised representative
Linus Health Europe IE-AR-000020899

Other devices from Linus Health

See all devices from Linus Health →

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 27f39b9f-a214-448e-926f-3b11c25efcba 61 fields · synced 22 Oct 2026