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Cromatic Detection, Uti

by Deltarom SRL Romania EUDAMED

Ref 342471

EMDN W0104010402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number594054038CROMATICDETEC2H2 Basic UDI-DIDate8 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
342471
Primary DI / UDI-DI
05940540387177
Basic UDI-DI
594054038CROMATICDETEC2H2
EMDN Code
W0104010402 Chromogenic id media (plates)
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 & 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 fe068463-c435-456e-b530-87b804f53839 61 fields · synced 24 Oct 2026