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RESIST-3 O.K.N. Carbapenemases rapid test

by Coris BioConcept Belgium EUDAMED

Ref K-15R5 EMDN W0104080506

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54200719K15R55R Basic UDI-DIDate28 May 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
K-15R5
Primary DI / UDI-DI
15420071900603
Basic UDI-DI
54200719K15R55R
Direct Marketing DI
15420071900603
EMDN Code
W0104080506 Targeted resistance tests - carbapenemase
Device Class
Class B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000024520

From the manufacturer

Manufacturer's product page: RESIST-3 O.O.K. K-SeT

Other devices from Coris BioConcept

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 0ef57ea2-4521-4930-b3e4-d816b0ced39a 61 fields · synced 24 Oct 2026