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SenSura Flex

by Coloplast A/S Denmark EUDAMED

Ref 11305

EMDN A1002010402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322976048S 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 23 Oct 2026

Device Name
SenSura Flex Xpro ostomy baseplate convex
Model / Reference
11305
Primary DI / UDI-DI
05708932402750, 05708932403801, 05708932403641
Basic UDI-DI
57089322976048S
Unit of Use DI
05708932963602, 05701780065948, 05701780065931
EMDN Code
A1002010402 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with introflex stoma
Device Class
Class I
Market of Registration
Germany
Norway
Liechtenstein

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 dfe84065-def6-4345-ab98-b15a0bfd0707 61 fields · synced 23 Oct 2026
  • EUDAMED 05708932403801|57089322976048S 61 fields · synced 17 May 2026
  • EUDAMED 05708932403641|57089322976048S 61 fields · synced 19 May 2026