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HDL Cholesterol (L.S) Direct

by Fortress Diagnostics Ltd XI EUDAMED

Ref MON0431B EMDN W01010215

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060476978123 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
LDL Cholesterol (L.S) Direct
Model / Reference
MON0431B
Primary DI / UDI-DI
05060476978123
Basic UDI-DI
B-05060476978123
EMDN Code
W01010215 High density lipoprotein cholesterol
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 & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 05060476978123|B-05060476978123 61 fields · synced 24 Oct 2026