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Systane

by Alcon Laboratories, Inc. 113 variants

Ref 0014290294, 0014290304, 0014290288, 0014290285, 0014290286, 0032900019, 0014810086, 0014810065, 0004310007, 0032900018

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038065GMN000084HB Basic UDI-DI Date31 Oct 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Alcon Lubricant Eye Drops
Model / Reference
0014290294, 0014290304, 0014290288, 0014290285, 0014290286, 0032900019, 0014810086, 0014810065, 0004310007, 0032900018
Primary DI / UDI-DI
00300651429091, 00300651429190, 00300651429039, 05015664005990, 08427324818357, 00300653290194, 00300651481860, 00300651481655, 05015664008052, 00300653290187
Basic UDI-DI
038065GMN000084HB
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class IIb
EU 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

  • 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