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Wavenet

by Alcon Laboratories, Inc. United States EUDAMED

Ref 6161

EMDN Z12120282

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038065GMN000167HG Basic UDI-DIDate4 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Laser application software
Model / Reference
6161
Primary DI / UDI-DI
00380659908163
Basic UDI-DI
038065GMN000167HG
EMDN Code
Z12120282 Therapeutic and surgical ophtholmological treatments instruments - software accessories
Device Class
Class IIb
Special Device Type
Software
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
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b0b3aa40-3493-4a63-a4aa-5e371c11de31 61 fields · synced 22 Oct 2026