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Alterna

by Coloplast A/S 502 variants

Ref 12836

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 Number570893295264294TS Basic UDI-DI Date19 Aug 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  • Withdrawn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
Coloplast, Assura/Alterna, SenSura Mio, Conseal Ostomy Irrigation Set products
Model / Reference
12836
Primary DI / UDI-DI
05701780994439, 05708932173582, 05701780883016, 05708932141093, 05708932752510, 05701780608947, 05701780584838, 05701780831956, 05708932154871, 05701780619738, 05708932141116
Basic UDI-DI
570893295264294TS
Unit of Use DI
05701780090209, 05701780090339, 05701780090155, 05701780090131, 05708932752497, 05701780090230, 05701780090315, 05701780090186, 05701780090278, 05708932196727, 05701780090247
EMDN Code
A100301 Abdominal ostomy irrigation kits
Device Class
Class I
EU market of registration
Portugal
Greece
Hungary
Slovakia
Cyprus
Belgium
Italy
Finland
Czechia
Spain
Slovenia

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