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AML1 (RUNX1) Breakapart Probe

by Cytocell Limited United Kingdom EUDAMED

Ref CE-LPH 027

EMDN W01060299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50558449LPH027JK Basic UDI-DIDate21 Mar 2023RegisteredStatusActive

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 027
Primary DI / UDI-DI
05055844906426
Basic UDI-DI
50558449LPH027JK
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

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

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 c82f55d8-e48d-4183-bf8b-179ffc4831a7 61 fields · synced 22 Oct 2026