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CELLDIFF+ LYSE with Key

by Fortress Diagnostics Ltd EUDAMED

Active European Union

Ref HAEM043A

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060476975269 Basic UDI-DIDate19 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
HAEM043A
Primary DI / UDI-DI
05060476975269
Basic UDI-DI
B-05060476975269
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class IVD General
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000028408

Other devices from Fortress Diagnostics Ltd

See all devices from Fortress Diagnostics Ltd →

Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No