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Ldl 80

by Erba Lachema s.r.o. Czech Republic EUDAMED

Ref BLT00041

EMDN W01010221

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8592156CCRE0028T7 Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ldl Direct
Model / Reference
BLT00041
Primary DI / UDI-DI
08592156078894
Basic UDI-DI
8592156CCRE0028T7
EMDN Code
W01010221 Low density lipoprotein cholesterol including sd-ldl
Device Class
Class B
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000024067

Other devices from Erba Lachema s.r.o.

See all devices from Erba Lachema s.r.o. →

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 08592156078894|8592156CCRE0028T7 61 fields · synced 24 Oct 2026