Skip to content

Systane

by Alcon Laboratories, Inc. United States EUDAMED

Ref 0014340098

EMDN Q02030206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038065GMN000088HK Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Alcon Lubricant Eye Drops
Model / Reference
0014340098
Primary DI / UDI-DI
08427324893682
Basic UDI-DI
038065GMN000088HK
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000016248
Authorised representative
Alcon Laboratories Belgium BE-AR-000014721

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
  • Animal Tissues
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08427324893682|038065GMN000088HK 61 fields · synced 24 Oct 2026