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Alterna

by Coloplast A/S Denmark EUDAMED

Ref 14224

EMDN A10020402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975839B Basic UDI-DIDate10 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Assura/Alterna (New Generation) urostomy bag 2-piece
Model / Reference
14224
Primary DI / UDI-DI
05701780393027, 05708932214438
Basic UDI-DI
57089322975839B
Unit of Use DI
05701780393041, 05701780104821
EMDN Code
A10020402 Urostomy bags for two-part systems, with tissue cover
Device Class
Class I
Market of Registration
Lithuania
Greece

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED f289d804-e52f-4ba1-8c32-9c89c885684d 61 fields · synced 23 Oct 2026
  • EUDAMED 05708932214438|57089322975839B 61 fields · synced 19 May 2026