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Alterna

by Coloplast A/S 502 variants

Ref 2833

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893229760994 Basic UDI-DI Date12 Feb 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  • Withdrawn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
Assura/Alterna (Original) ostomy baseplate
Model / Reference
2833
Primary DI / UDI-DI
05701780856744, 05708932580885, 05708932272902, 05701780999106, 05708932197915, 05708932376525, 05708932300018, 05708932270229, 05701780875370
Basic UDI-DI
570893229760994
Unit of Use DI
05701780026123, 05708932580908, 05701780026062, 05701780026499, 05701780026154, 05701780025935, 05701780026420, 05701780025959, 05701780026284
EMDN Code
A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
Device Class
Class I
EU market of registration
Italy
Bulgaria
Croatia
Finland
Portugal
Estonia
Lithuania
Türkiye
Belgium

Manufacturer details

EUDAMED SRN
DK-MF-000025526

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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