Skip to content

SenSura Mio

by Coloplast A/S Denmark EUDAMED

Ref 197870

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
197870
Primary DI / UDI-DI
05701780350778
Basic UDI-DI
570893229753794
Unit of Use DI
05701780352338
EMDN Code
A10020302 Ileostomy bags for two-part systems, with tissue cover
Device Class
Class I
Market of Registration
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 (1)

  • EUDAMED cf4071d8-8dcc-41bf-9df9-5b76a9721bef 61 fields · synced 23 Oct 2026