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SenSura Mio

by Coloplast A/S Denmark EUDAMED

Ref 18642

EMDN A10020202

Regulatory status

as of 25 Oct 2026

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

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 High Output click ostomy bag 2-piece
Model / Reference
18642
Primary DI / UDI-DI
05708932071932, 05701780247504, 05708932044349, 05708932043298
Basic UDI-DI
57089322976299A
Unit of Use DI
05701780151214, 05701780248587, 05701780151245, 05708932066396
EMDN Code
A10020202 Colostomy bags for two-part systems, with tissue cover
Device Class
Class I
Market of Registration
Netherlands
Liechtenstein
Denmark
Germany

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 (4)

  • EUDAMED 0fab5148-68a3-4807-b12c-0fab87daf5ac 61 fields · synced 23 Oct 2026
  • EUDAMED 05701780247504|57089322976299A 61 fields · synced 17 May 2026
  • EUDAMED 05708932044349|57089322976299A 61 fields · synced 19 May 2026
  • EUDAMED 05708932043298|57089322976299A 61 fields · synced 19 May 2026