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OPAL® II Behandlungsset Classic

by Albutec GmbH Germany EUDAMED

Ref 80003-II

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
Primary DI / UDI-DI
04260430940628
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

See all devices from Albutec GmbH →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 5691b6a9-52e3-43cf-a8ea-af61e1b2dbd1 61 fields · synced 22 Oct 2026