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SenSura Mio

by Coloplast A/S Denmark EUDAMED

Ref 18613 EMDN A10020202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322976299A Basic UDI-DIDate11 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
SenSura Mio High Output click ostomy bag 2-piece
Model / Reference
18613
Primary DI / UDI-DI
05708932044578, 05708932045988
Basic UDI-DI
57089322976299A
Unit of Use DI
05701780150217, 05701780150125
EMDN Code
A10020202 Colostomy bags for two-part systems, with tissue cover
Device Class
Class I
Market of Registration
Denmark
Finland

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 (2)

  • EUDAMED cd88748b-82df-440c-8952-3bf250eadc37 61 fields · synced 25 Oct 2026
  • EUDAMED 05708932045988|57089322976299A 61 fields · synced 19 May 2026