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A-800 Hdl Direct

by PZ CORMAY Spółka Akcyjna Poland EUDAMED

Ref 7-815Model A-800 HDL DIRECT

EMDN W01010220

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514678150 Basic UDI-DIDate20 May 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 24 Oct 2026

Device Name
Hdl Direct
Model / Reference
A-800 HDL DIRECT, 7-815
Primary DI / UDI-DI
05907514678150
Basic UDI-DI
B-05907514678150
EMDN Code
W01010220 Lipoprotein, chemical determination/detection
Device Class
Class IVD General
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
PL-MF-000023053

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 70c5cf40-7c4f-4be5-8ef8-3aea0546902b 61 fields · synced 24 Oct 2026