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GXD5 Diagnostics

by Enovacom France EUDAMED

Ref GXD5 Diagnostics 1.9 EMDN Z11069092

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-GXD5DIAGSGH Basic UDI-DIDate17 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
GXD5 Diagnostics
Model / Reference
GXD5 Diagnostics 1.9
Primary DI / UDI-DI
D-GXD5DIAGSGH
Basic UDI-DI
B-GXD5DIAGSGH
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000686

Other devices from Enovacom

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8c36b424-d125-4572-87ca-8a815fdba161 61 fields · synced 22 Oct 2026