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Myt-CAL

by Orphée SA Switzerland EUDAMED

Ref MYTCAL2

EMDN W0103010507

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07640142480549 Basic UDI-DIDate28 Jan 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 22 Oct 2026

Model / Reference
MYTCAL2
Primary DI / UDI-DI
07640142480549
Basic UDI-DI
B-07640142480549
EMDN Code
W0103010507 Whole blood calibrators
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
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9f18c922-1088-4975-989a-9e54f6b281db 61 fields · synced 22 Oct 2026