Skip to content

Mythic 18

by Orphée SA Switzerland EUDAMED

Ref M18OT

EMDN W0202010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07640142480396 Basic UDI-DIDate13 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
M18OT
Primary DI / UDI-DI
07640142480396
Basic UDI-DI
B-07640142480396
EMDN Code
W0202010201 Automated 3 part hematology analysers
Device Class
Class IVD General
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
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 05080d51-ec0d-4445-bcb5-1f2b08e78d6d 61 fields · synced 24 Oct 2026