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Cromatic Esbl

by Deltarom SRL Romania EUDAMED

Ref 342411, 342415 EMDN W0104010402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number594054038CROMATICESBL23HY 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
342411, 342415
Primary DI / UDI-DI
05940540387351, 05940540387375
Basic UDI-DI
594054038CROMATICESBL23HY, 594054038CROMATICESBL01HN
EMDN Code
W0104010402, W0104010101
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 (2)

  • EUDAMED b577d2ba-b5fa-49b2-962e-9b8e79c9e1db 61 fields · synced 22 Oct 2026
  • EUDAMED 05940540387375|594054038CROMATICESBL01HN 61 fields · synced 18 May 2026