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Cube Reader

by opTricon GmbH Germany EUDAMED

Ref CUBE-802, CUBE-755, CUBE-156-01-01

EMDN W0201020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42520204CUBEDQ Basic UDI-DIDate15 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CUBE-802, CUBE-755, CUBE-156-01-01
Primary DI / UDI-DI
04252020400063, 04252020400087, 04252020400070, 04252020400032, 04252020400100, 04252020400025, 04252020400094
Basic UDI-DI
42520204CUBEDQ
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000024656

Other devices from opTricon GmbH

See all devices from opTricon GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (7)

  • EUDAMED 2f4756b6-bf2f-4daf-b54a-2db999c2d938 61 fields · synced 22 Oct 2026
  • EUDAMED 04252020400087|42520204CUBEDQ 61 fields · synced 17 May 2026
  • EUDAMED 04252020400070|42520204CUBEDQ 61 fields · synced 17 May 2026
  • EUDAMED 04252020400032|42520204CUBEDQ 61 fields · synced 18 May 2026
  • EUDAMED 04252020400100|42520204CUBEDQ 61 fields · synced 18 May 2026
  • EUDAMED 04252020400025|42520204CUBEDQ 61 fields · synced 18 May 2026
  • EUDAMED 04252020400094|42520204CUBEDQ 61 fields · synced 19 May 2026