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KarbaDia Rapid Test

by GaDia SA Switzerland EUDAMED

Ref KAR-025

EMDN W0104080506

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07649990065052 Basic UDI-DIDate25 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
KAR-025
Primary DI / UDI-DI
07649990065052
Basic UDI-DI
B-07649990065052
EMDN Code
W0104080506 Targeted resistance tests - carbapenemase
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000031123
Authorised representative
ER Egészségügyi, Kereskedelmi és Szolgáltató Kft. HU-AR-000030559

Other devices from GaDia SA

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED febb3594-4ad3-43e6-872b-388a72cfd0a7 61 fields · synced 22 Oct 2026