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SenSura Flex

by Coloplast A/S Denmark EUDAMED

Ref 118210

EMDN A10020402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975749A Basic UDI-DIDate23 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
SenSura Flex urostomy bag 2-piece
Model / Reference
118210
Primary DI / UDI-DI
05708932395687, 05708932396042, 05708932396172
Basic UDI-DI
57089322975749A
Unit of Use DI
05701780073905, 05701780073974, 05708932396165
EMDN Code
A10020402 Urostomy bags for two-part systems, with tissue cover
Device Class
Class I
Market of Registration
Austria
Sweden
France

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

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 (3)

  • EUDAMED 1dde486c-277d-4b3d-9f2b-8903e2511cbd 61 fields · synced 22 Oct 2026
  • EUDAMED 05708932396042|57089322975749A 61 fields · synced 17 May 2026
  • EUDAMED 05708932396172|57089322975749A 61 fields · synced 19 May 2026