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SenSura Mio Convex Flip

by Coloplast A/S Denmark EUDAMED

Ref 18185

EMDN A1001010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975098X 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 closed
Model / Reference
18185
Primary DI / UDI-DI
05708932744775, 05708932034463
Basic UDI-DI
57089322975098X
Unit of Use DI
05708932744768, 05701780144483
EMDN Code
A1001010201 One-piece colostomy bags for retracted stoma, convex, w/o tissue cover
Device Class
Class I
Market of Registration
Slovakia
Italy

Manufacturer details

EUDAMED SRN
DK-MF-000025526

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 14104878-db29-4cbd-9c4a-05d80e5af87b 61 fields · synced 24 Oct 2026
  • EUDAMED 05708932034463|57089322975098X 61 fields · synced 12 Oct 2026