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IsoFree® (Muster)

by Penta Arzneimittel GmbH Germany EUDAMED

Ref 41041600Model Inhalation Solution

EMDN R060203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426059553MP09UD01LG Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sodium Chloride 0.9% Inhalation Solution
Model / Reference
Inhalation Solution, 41041600
Primary DI / UDI-DI
14260595531553
Basic UDI-DI
426059553MP09UD01LG
EMDN Code
R060203 Inhalation therapy humidification liquids
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006565

Other devices from Penta Arzneimittel GmbH

See all devices from Penta Arzneimittel GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 763a4902-0d81-45a1-9b14-f8901c475ca3 61 fields · synced 24 Oct 2026