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OPAL I Behandlungsset Premium

by Albutec GmbH Germany EUDAMED

Ref 80004

EMDN F0399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426043094OPALSETGS Basic UDI-DIDate11 Jan 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
OPAL Treatment Sets
Model / Reference
80004
Primary DI / UDI-DI
04260430940109
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 3ca11eb7-526a-4c31-a5d1-d4e8ff76be51 61 fields · synced 22 Oct 2026