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SenSura Mio Convex Flip

by Coloplast A/S Denmark EUDAMED

Ref 18285

EMDN A100199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975408R Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SenSura Mio Concave ostomy bag 1-piece open
Model / Reference
18285
Primary DI / UDI-DI
05708932034708, 05708932126458
Basic UDI-DI
57089322975408R
Unit of Use DI
05701780145978, 05701780145954
EMDN Code
A100199 Devices for abdominal ostomy - one piece - other
Device Class
Class I
Market of Registration
Italy
Slovakia

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Related devices

Category: One-piece intestinal ostomy bag, closed-ended

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 978a1e5d-21c4-4690-95e9-1a670b122b71 61 fields · synced 24 Oct 2026
  • EUDAMED 05708932126458|57089322975408R 61 fields · synced 14 Oct 2026