Skip to content

Os-Hdl Direct

by PZ CORMAY Spółka Akcyjna Poland EUDAMED

Ref 9-411Model OS-HDL DIRECT

EMDN W01010220

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514694112 Basic UDI-DIDate21 Jul 2025RegisteredStatusActive

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 22 Oct 2026

Device Name
Hdl Direct
Model / Reference
OS-HDL DIRECT, 9-411
Primary DI / UDI-DI
05907514694112
Basic UDI-DI
B-05907514694112
EMDN Code
W01010220 Lipoprotein, chemical determination/detection
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

Other devices from PZ CORMAY Spółka Akcyjna

See all devices from PZ CORMAY Spółka Akcyjna →

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 dd93e3f4-c3ec-4e6f-b80d-8329fda70c83 61 fields · synced 22 Oct 2026