Skip to content

CAPSULaser Cataract System

by EXCEL-LENS, Inc. EUDAMED 3 variants

Active European Union

Ref 178-0295

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00860000945325 Basic UDI-DIDate30 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
CAPSULaser Cataract System, Zeiss
Model / Reference
178-0295
Primary DI / UDI-DI
00860000945325
Basic UDI-DI
B-00860000945325
EMDN Code
Z12011006 Diode–pumped solid–state (dpss) surgical laser
Device Class
Class IIb
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
US-MF-000032977
Authorised representative
ELS SOLUTIONS GDIA - UNIPESSOAL LDA. PT-AR-000026128

Other devices from EXCEL-LENS, Inc.

Properties

Other properties (11)

  • Sterile: No
  • 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