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Assura

by Coloplast A/S Denmark EUDAMED

Ref 12992

EMDN A1001030202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975779G Basic UDI-DIDate5 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Assura/Alterna (Original) urostomy bag 1-piece convex
Model / Reference
12992
Primary DI / UDI-DI
05701780549455, 05701780548564
Basic UDI-DI
57089322975779G
Unit of Use DI
05708932962223, 05701780091343
EMDN Code
A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
Device Class
Class I
Market of Registration
Germany
Liechtenstein

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 c17da9c9-6e12-44fe-af92-bf0abe88343b 61 fields · synced 24 Oct 2026
  • EUDAMED 05701780548564|57089322975779G 61 fields · synced 19 May 2026