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Babycap®

by Laboratoire Unither France EUDAMED

Ref 5 902020 672654Model Sterile hypertonic solution of sodium chloride 3% in vials for inhalation EMDN R0699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-5902020672654VR 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
Sterile hypertonic solution of sodium chloride 3% in vials for inhalation, 5 902020 672654
Primary DI / UDI-DI
D-5902020672654VR
Basic UDI-DI
B-5902020672654VR
EMDN Code
R0699 Nebulisation and humidification systems - other
Device Class
Class IIa
Market of Registration
Poland

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 1b15112f-7cec-42ee-b9a3-603769b1e30a 61 fields · synced 25 Oct 2026