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SoFarma SOLUZIONE ISOTONICA multiuso

by Laboratoire Unither France EUDAMED

Ref 8 388766 675864Model 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 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8388766675864KL Basic UDI-DIDate15 Sep 2025RegisteredStatusActive

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  • Withdrawn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 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 388766 675864
Primary DI / UDI-DI
D-8388766675864KL
Basic UDI-DI
B-8388766675864KL
EMDN Code
Q02030299,Q030103,Q03040299,R060203,V9099
Device Class
Class IIa
Market of Registration
Italy

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 446e8427-8f47-4bce-a5ea-24b41951cef2 61 fields · synced 22 Oct 2026