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Hemax

by Delta Care for Medical Industries Co, Ltd. EUDAMED 19 variants

Active European Union EUDAMED: not on the EU market

Ref DC144

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number622301829DILCJ Basic UDI-DIDate9 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Hematology Analyzer Reagent (Diluent/Lyse/Cleaner)
Model / Reference
DC144
Primary DI / UDI-DI
06223018290889
Basic UDI-DI
622301829DILCJ
Direct Marketing DI
06223018290889
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A

Manufacturer details

EUDAMED SRN
EG-MF-000044132
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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