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by Bausch & Lomb Incorporated United States EUDAMED

Ref WBTC V2.4 EMDN Z12120292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0310119B1028ZL Basic UDI-DIDate25 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Ophthalmic Software
Model / Reference
WBTC V2.4
Primary DI / UDI-DI
10757770636126
Basic UDI-DI
0310119B1028ZL
Direct Marketing DI
10757770636126
EMDN Code
Z12120292 Therapeutic and surgical ophtholmological treatments instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001029
Authorised representative
Bausch & Lomb GmbH DE-AR-000006810

Other devices from Bausch & Lomb Incorporated

See all devices from Bausch & Lomb Incorporated →

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 10757770636126|0310119B1028ZL 61 fields · synced 25 Oct 2026