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imazine

by Laboratoire Unither EUDAMED

Active European Union

Ref 8 437028 980472Model Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-84370289804728G Basic UDI-DIDate27 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

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 437028 980472
Primary DI / UDI-DI
D-84370289804728G
Basic UDI-DI
B-84370289804728G
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

  • 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