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Assura

by Coloplast A/S Denmark EUDAMED

Ref 12994

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 22 Oct 2026

Trade Name
Assura
Alterna
Device Name
Assura/Alterna (Original) urostomy bag 1-piece convex
Model / Reference
12994
Primary DI / UDI-DI
05701780389686, 05701780858410, 05701780549493
Basic UDI-DI
57089322975779G
Unit of Use DI
05701780091572, 05701780091527, 05708932962209
EMDN Code
A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
Device Class
Class I
Market of Registration
Netherlands
Italy
Germany

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 (3)

  • EUDAMED 3c2c6008-1fd4-4eb5-98f1-f13fe4870574 61 fields · synced 22 Oct 2026
  • EUDAMED 05701780858410|57089322975779G 61 fields · synced 16 May 2026
  • EUDAMED 05701780549493|57089322975779G 61 fields · synced 17 May 2026