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CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

by Cytocell Limited United Kingdom EUDAMED

Ref CE-LPH 022

EMDN W01060211

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50558449LPH022J9 Basic UDI-DIDate4 Apr 2024RegisteredStatusActive

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
CE-LPH 022
Primary DI / UDI-DI
05055844906341, 05055844923591
Basic UDI-DI
50558449LPH022J9
EMDN Code
W01060211 Inv (16)
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000016893
Authorised representative
Sysmex Europe SE DE-AR-000022333

Other devices from Cytocell Limited

See all devices from Cytocell Limited →

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 47a8a82f-e06e-4ab3-87f0-352b3d5a795c 61 fields · synced 22 Oct 2026
  • EUDAMED f71e27e9-0b1c-44f5-9c5e-dc69e3f03317 61 fields · synced 21 Jul 2026