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Alterna

by Coloplast A/S 502 variants

Ref 13985

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 Number57089322975508U Basic UDI-DI Date12 Dec 2025RegisteredStatusActive

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  • Withdrawn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

Trade Name
Alterna
Assura
Device Name
Assura/Alterna (New Generation) ostomy bag 2-piece open
Model / Reference
13985
Primary DI / UDI-DI
05708932270106, 05701780760102, 05701780894517, 05708932167697, 05701780771559, 05701780809870, 05708932152716, 05708932511049, 05701780818919
Basic UDI-DI
57089322975508U
Unit of Use DI
05701780099455, 05708932961875, 05701780099479, 05701780099820, 05701780099837, 05701780099516, 05701780099813, 05701780099790, 05701780099660
EMDN Code
A10020202, A10020302
Device Class
Class I
EU market of registration
Türkiye
Germany
Finland
Croatia
Norway
Italy
Portugal
Estonia
Ireland

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