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Candida Cromogen

by Deltarom SRL EUDAMED

Active European Union

Ref 342318, 342315, 342311, 342317

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number594054038CANDIDACROMOG1HR Basic UDI-DIDate7 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
342318, 342315, 342311, 342317
Primary DI / UDI-DI
05940540387559, 05940540387566, 05940540387535, 05940540387542
Basic UDI-DI
594054038CANDIDACROMOG1HR, 594054038CANDIDACROMOGEJX, 594054038CANDIDACROMOG4HX, 594054038CANDIDACROMOG2HT
EMDN Code
W0104010306, W0104010101, W0104010402, W0104010206
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000035924

Other devices from Deltarom SRL

See all devices from Deltarom SRL →

Properties

Show properties
  • 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