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Lipaza 40 ml R1 + 8 ml R2 + kalibrator

by BioMaxima Spółka Akcyjna Poland EUDAMED

Ref 1-250-0048

EMDN W01010123

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439BBCH250AG Basic UDI-DIDate21 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Lipaza 40 ml R1 + 8 ml R2 + kalibrator
Model / Reference
1-250-0048
Primary DI / UDI-DI
05902643961821
Basic UDI-DI
59026439BBCH250AG
EMDN Code
W01010123 Lipase
Device Class
Class B
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 389b86ce-4a3d-4777-a05d-776f53291827 61 fields · synced 22 Oct 2026