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Pathosolutions – PathAlc, 500ml

by Grzegorz Pałkowski Elektro Med Poland EUDAMED

Ref EM-R8001011

EMDN W01030799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number590518640EM-R800101XM Basic UDI-DIDate20 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Pathosolutions – PathAlc
Model / Reference
EM-R8001011
Primary DI / UDI-DI
05905186401830
Basic UDI-DI
590518640EM-R800101XM
Direct Marketing DI
05905186401830
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023609

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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 a083c943-03ef-4aa0-849a-5eb0b9194801 61 fields · synced 23 Oct 2026