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cymactive™ 2.0R Bladder Manager System (BMS) Catheter

by Ingenion Medical Ltd. United Kingdom EUDAMED

Ref CYM-2R-12 EMDN U010103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number050610063500CatheterMY Basic UDI-DIDate14 May 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  • Withdrawn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 24 Oct 2026

Model / Reference
CYM-2R-12
Primary DI / UDI-DI
05061006350006
Basic UDI-DI
050610063500CatheterMY
EMDN Code
U010103 Urethral prostatic and bladder catheters, malecot
Device Class
Class IIb
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
  • 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

Sources (1)

  • EUDAMED ee668825-22c5-4df1-8c31-1e6ae029007c 61 fields · synced 24 Oct 2026