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Mythic 18 Diluent

by Orphée SA Switzerland EUDAMED

Ref HM18-009-20

EMDN W0103010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number764014248HM18-00933 Basic UDI-DIDate9 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HM18-009-20
Primary DI / UDI-DI
07640142480020
Basic UDI-DI
764014248HM18-00933
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CH-MF-000050926
Authorised representative
PZ CORMAY Spółka Akcyjna PL-AR-000026245

Other devices from Orphée SA

See all devices from Orphée SA →

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 1f9800b8-56d4-4fe1-badb-8e6ea54eb8cd 61 fields · synced 22 Oct 2026