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OPAL® II Behandlungsset MC5

by Albutec GmbH Germany EUDAMED

Ref 80003-II-MC5

EMDN F0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426043094OPALSETGS Basic UDI-DIDate11 Jan 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
OPAL Treatment Sets
Model / Reference
80003-II-MC5
Primary DI / UDI-DI
04260430940840
Basic UDI-DI
426043094OPALSETGS
EMDN Code
F0399 Dialysis kits - other
Device Class
Class IIa
Medical Purpose
Liver Support, Kidney Support, Albumin Dialysis

Manufacturer details

EUDAMED SRN
DE-PR-000009770

Other devices from Albutec GmbH

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 923a92a9-3e45-4e2b-95f1-046cba4392da 61 fields · synced 22 Oct 2026