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SenSura Mio

by Coloplast A/S Denmark EUDAMED

Ref 11973

EMDN A10020302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893229753794 Basic UDI-DIDate9 Jan 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 Mio flex ostomy bag 2-piece open
Model / Reference
11973
Primary DI / UDI-DI
05708932930222, 05708932920322, 05708932944465
Basic UDI-DI
570893229753794
Unit of Use DI
05708932931014, 05708932921176, 05708932945066
EMDN Code
A10020302 Ileostomy bags for two-part systems, with tissue cover
Device Class
Class I
Market of Registration
Finland
Ireland
Denmark

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 aa12a93e-3a8f-402c-b4c0-f68262a50278 61 fields · synced 23 Oct 2026
  • EUDAMED 05708932920322|570893229753794 61 fields · synced 18 May 2026
  • EUDAMED 05708932944465|570893229753794 61 fields · synced 19 May 2026