Skip to content

Bronchlear 3%

by Laboratoire Unither France EUDAMED

Ref 5 060611 190731 Model Sterile hypertonic solution of sodium chloride 3% in vials for inhalation

EMDN R0699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-5060611190731RL Basic UDI-DIDate6 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Sterile hypertonic solution of sodium chloride 3% in vials for inhalation, 5 060611 190731
Primary DI / UDI-DI
D-5060611190731RL
Basic UDI-DI
B-5060611190731RL
EMDN Code
R0699 Nebulisation and humidification systems - other
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
FR-MF-000004062

Other devices from Laboratoire Unither

See all devices from Laboratoire Unither →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 10b18988-ac5e-4b6c-8632-b674522ebc14 61 fields · synced 22 Oct 2026