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Pathosolutions – PathAlc 96, 500ml

by Grzegorz Pałkowski Elektro Med

Ref EM-R18001021

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number590518640EM-R1800102xTB Basic UDI-DI 05905186402059UDI-DIDate9 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Pathosolutions – PathAlc 96
Model / Reference
EM-R18001021
Primary DI / UDI-DI
05905186402059
Basic UDI-DI
590518640EM-R1800102xTB
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023609

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Properties

  • Reagent

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No