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100% Silicone Foley Catheter

by Curas Sdn. Bhd. Malaysia EUDAMED

Ref 20036 EMDN U010206

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05051400200366 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
100% Silicone Foley Catheter
Model / Reference
20036
Primary DI / UDI-DI
05051400200366
Basic UDI-DI
B-05051400200366
EMDN Code
U010206 Urethral prostatic and bladder catheters, tiemann with balloon
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
MY-MF-000036883
Authorised representative
Kabomed GmbH AT-AR-000007569

Other devices from Curas Sdn. Bhd.

See all devices from Curas Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • 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

Sources (1)

  • EUDAMED 77b87dcf-99c1-4ed5-93b6-1dc091e55b33 61 fields · synced 22 Oct 2026