Skip to content

Double Arm Cystotome 30G

by PSI/EYE-KO, Inc. EUDAMED

Active European Union

Ref 5000HModel Irrigating Cystotomes and Capsulorhexis Cystotomes

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08405161500054 Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR 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

Model / Reference
Irrigating Cystotomes and Capsulorhexis Cystotomes, 5000H
Primary DI / UDI-DI
00840516144597
Basic UDI-DI
08405161500054
EMDN Code
Q021101 Occular irrigation and aspiration cannulas, single-use
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000022109
Authorised representative
Advena SRL IT-AR-000051131

Other devices from Psi/Eye-Ko, Inc.

See all devices from Psi/Eye-Ko, Inc. →

Properties

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