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cymactive™ 2.0R Bladder Manager System (BMS) Actuator

by Ingenion Medical Ltd. United Kingdom EUDAMED

Ref 630

EMDN U0180

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number050610063500ActuatorSD Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
630
Primary DI / UDI-DI
05061006350013
Basic UDI-DI
050610063500ActuatorSD
EMDN Code
U0180 Urethral prostatic and bladder catheters - accessories
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000041065
Authorised representative
CS Life Sciences Europe Ltd IE-AR-000004113

Other devices from Ingenion Medical Ltd.

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 9c4542f0-11db-45e7-98d0-ff3d84763fae 61 fields · synced 24 Oct 2026