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SenSura Mio

by Coloplast A/S 637 variants

Ref 10685

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 Number57089322975058P 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  • Withdrawn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 closed
Model / Reference
10685
Primary DI / UDI-DI
05708932934411, 05708932930697, 05708932634243, 05708932918312, 05708932945820, 05708932920896, 05708932939133
Basic UDI-DI
57089322975058P
Unit of Use DI
05708932935319, 05708932931489, 05701780055697, 05708932919180, 05708932945554, 05708932921749, 05701780055680
EMDN Code
A1001010102 One-piece colostomy bags for non-retracted stoma, flat, with tissue cover
Device Class
Class I
EU market of registration
Netherlands
Finland
Czechia
Norway
Denmark
Ireland
Liechtenstein

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