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SenSura Mio Convex

by Coloplast A/S 574 variants

Ref 16825

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975689F Basic UDI-DI Date17 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SenSura Mio Convex urostomy bag 1-piece
Model / Reference
16825
Primary DI / UDI-DI
05701780441087, 05708932857055, 05701780441117, 05708932685061, 05701780440967, 05701780177207, 05708932862189, 05701780440998, 05708932874946, 05708932885744, 05701780441179, 05701780441056, 05701780441261, 05701780441025, 05708932872638, 05708932613897, 05701780441148, 05708932877077
Basic UDI-DI
57089322975689F
Unit of Use DI
05701780441100, 05708932859059, 05701780441131, 05708932685054, 05701780440981, 05701780136051, 05708932862721, 05701780441018, 05708932875707, 05708932886482, 05701780441193, 05701780441070, 05701780441285, 05701780441049, 05708932873406, 05708932625234, 05701780441162, 05708932877756
EMDN Code
A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
Device Class
Class I
EU market of registration
Denmark
Norway
Belgium
Netherlands
Slovenia
Ireland
Germany
Liechtenstein
Finland
Italy

Manufacturer details

EUDAMED SRN
DK-MF-000025526

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See all devices from Coloplast A/S →

Properties

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