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SenSura

by Coloplast A/S 443 variants

Ref 15281

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 Number57089322975418T Basic UDI-DI Date8 Jul 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  • Withdrawn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 ostomy bag 1-piece open
Model / Reference
15281
Primary DI / UDI-DI
05701780179539, 05708932481090, 05701780274142, 05708932727723, 05701780257947, 05708932444750, 05708932749374, 05708932443142, 05708932443975, 05708932480031, 05708932743655
Basic UDI-DI
57089322975418T
Unit of Use DI
05708932786867, 05701780126960, 05701780274036, 05701780127004, 05701780257961, 05701780126984, 05708932749350, 05701780126977, 05701780127028, 05701780126991, 05701780283571
EMDN Code
A1001010102, A1001020102
Device Class
Class I
EU market of registration
Lithuania
Czechia
Spain
Estonia
Cyprus
Belgium
Portugal
Greece
Italy
Slovakia
Hungary

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