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Cleo Connect

by Primaa France EUDAMED

Ref CLEOCT1.9, CLEOCT1.OModel CLEOCT1.0 EMDN W02029082

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770027071PRM_CL_CTW2 Basic UDI-DIDate25 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CLEOCT1.0, CLEOCT1.9, CLEOCT1.O
Primary DI / UDI-DI
03770027071044, 03770027071020
Basic UDI-DI
3770027071PRM_CL_CTW2
EMDN Code
W02029082 Various hematology / histology / cytology instruments - software accessories
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000016215

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED b25012ba-36b8-416e-83a1-85bef4e67511 61 fields · synced 22 Oct 2026
  • EUDAMED 03770027071020|3770027071PRM_CL_CTW2 61 fields · synced 17 May 2026