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SenSura

by Coloplast A/S 452 variants

Ref 19011

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322976228U Basic UDI-DI Date25 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SenSura Post op ostomy bag 1-piece sterile
Model / Reference
19011
Primary DI / UDI-DI
05708932515924, 05708932973175, 05708932496377, 05708932973083, 05708932494779, 05708932972680, 05708932972949, 05708932973045, 05708932972819, 05708932971935, 05708932973137, 05708932494830, 05708932976992
Basic UDI-DI
57089322976228U
Unit of Use DI
05708932135085
EMDN Code
A1001010102, A1001020102
Device Class
Class I
EU market of registration
Croatia
Liechtenstein
Slovenia
Germany
Czechia
Netherlands
Belgium
Norway
Spain
Italy
Ireland
Portugal
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile

Other properties (12)

  • 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