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SenSura Mio

by Coloplast A/S 637 variants

Ref 10581

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 Number570893229756599 Basic UDI-DI Date11 May 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  • Withdrawn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 urostomy bag 1-piece
Model / Reference
10581
Primary DI / UDI-DI
05708932939003, 05701780431453, 05708932946087, 05708932932516, 05708932912730, 05701780431361, 05701780431422, 05701780431309, 05708932942027, 05701780431330
Basic UDI-DI
570893229756599
Unit of Use DI
05701780053983, 05701780431477, 05708932945684, 05701780054003, 05708932912778, 05701780431385, 05701780431446, 05701780431323, 05708932940023, 05701780431354
EMDN Code
A1001030102 One-piece urostomy bags for non-retracted stoma, flat, with tissue cover
Device Class
Class I
EU market of registration
Liechtenstein
Czechia
Denmark
Italy
Finland
Austria
Poland
Norway
Germany

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