Skip to content

Sterile Bladder Irrigation Sets for Single Use

by Vitaimed Instrument Co., Ltd. EUDAMED

Active European Union

Ref KY-IR-6-5Model KY-IR-6-1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number695505370235KY-IR-6-1PZ Basic UDI-DIDate22 Nov 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
KY-IR-6-1, KY-IR-6-5
Primary DI / UDI-DI
06955053702392
Basic UDI-DI
695505370235KY-IR-6-1PZ
Direct Marketing DI
06955053702392
EMDN Code
A03040201 Bladder irrigation kits, single-use
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000033172
Authorised representative
VITAIMED GmbH DE-AR-000029575

Other devices from Vitaimed Instrument Co., Ltd.

See all devices from Vitaimed Instrument Co., Ltd. →

Properties

Show properties
  • Sterile
Other properties (12)
  • 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