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by Laboratoire Unither France EUDAMED

Ref 8 430321 006375 , 8 430321 717387Model Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

EMDN Q02030299,Q030103,Q03040299,R060203,V9099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8430321006375TE Basic UDI-DIDate21 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 isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation, 8 430321 006375, 8 430321 717387
Primary DI / UDI-DI
D-8430321006375TE, D-8430321717387X2
Basic UDI-DI
B-8430321006375TE, B-8430321717387X2
EMDN Code
Q02030299,Q030103,Q03040299,R060203,V9099
Device Class
Class IIa
Market of Registration
Spain

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 (2)

  • EUDAMED 6c9a2a2e-7e60-4f1e-8b87-1d802a2fcd63 61 fields · synced 22 Oct 2026
  • EUDAMED D-8430321717387X2|B-8430321717387X2 61 fields · synced 18 May 2026