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Alvita®

by Laboratoire Unither France EUDAMED

Ref 5 055382 317357Model Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation EMDN R060203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-5055382317357X8 Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

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  • Withdrawn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 24 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, 5 055382 317357
Primary DI / UDI-DI
D-5055382317357X8
Basic UDI-DI
B-5055382317357X8
EMDN Code
R060203 Inhalation therapy humidification liquids
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 (1)

  • EUDAMED 506e596d-772b-492b-90f5-f3ce8ed13091 61 fields · synced 24 Oct 2026