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MediBrite

by Artinis Medical Systems B.V. Netherlands EUDAMED

Ref MediBrite SModel MediBrite

EMDN Z12109006

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number87208922058MediBritePU Basic UDI-DIDate1 Jul 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

Model / Reference
MediBrite, MediBrite S
Primary DI / UDI-DI
08720892205810
Basic UDI-DI
87208922058MediBritePU
Direct Marketing DI
08720892205810
EMDN Code
Z12109006 Brain tissue monitoring systems
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000036549

Other devices from Artinis Medical Systems B.V.

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 48391508-aa09-4b42-b3f2-ca0c2e4d48cd 61 fields · synced 22 Oct 2026