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SenSura Mio

by Coloplast A/S 637 variants

Ref 10401

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 Number570893229753692 Basic UDI-DI Date19 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  • Withdrawn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 ostomy bag 1-piece open
Model / Reference
10401
Primary DI / UDI-DI
05708932634281, 05708932946322, 05708932930680, 05708932920872, 05708932918299, 05708932939119, 05708932934404
Basic UDI-DI
570893229753692
Unit of Use DI
05701780051507, 05708932945806, 05708932931472, 05708932921725, 05708932919166, 05701780051514, 05708932935302
EMDN Code
A1001020102 One-piece ileostomy bags for non-retracted stoma, flat, with tissue cover
Device Class
Class I
EU market of registration
Czechia
Denmark
Finland
Ireland
Norway
Liechtenstein
Netherlands

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

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