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Respisun

by Laboratoire Unither EUDAMED

Active European Union

Ref 5 949477 000098, 6 425746 002219Model Sterile hypertonic solution of sodium chloride 3% in vials for inhalation

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-5949477000098C2 Basic UDI-DIDate21 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Sterile hypertonic solution of sodium chloride 3% in vials for inhalation, 5 949477 000098, 6 425746 002219
Primary DI / UDI-DI
D-5949477000098C2, D-6425746002219ZS
Basic UDI-DI
B-5949477000098C2, B-6425746002219ZS
EMDN Code
R0699 Nebulisation and humidification systems - other
Device Class
Class IIa
Market of Registration
Bulgaria
Romania

Manufacturer details

EUDAMED SRN
FR-MF-000004062

Other devices from Laboratoire Unither

See all devices from Laboratoire Unither →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No