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LDL cholesterol (direct)

by Clinichem Ltd. Hungary EUDAMED

Ref 43161

EMDN W01010221

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-43161MF0000410602Z Basic UDI-DIDate10 Sep 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 25 Oct 2026

Model / Reference
43161
Primary DI / UDI-DI
D-43161MF0000410602Z
Basic UDI-DI
B-43161MF0000410602Z
EMDN Code
W01010221 Low density lipoprotein cholesterol including sd-ldl
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000041060

Other devices from Clinichem Ltd.

See all devices from Clinichem Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-43161MF0000410602Z|B-43161MF0000410602Z 61 fields · synced 25 Oct 2026