Skip to content

Assura

by Coloplast A/S Denmark EUDAMED

Ref 14212

EMDN A1001030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893229758197 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 22 Oct 2026

Device Name
Assura/Alterna (New Generation) urostomy bag 1-piece
Model / Reference
14212
Primary DI / UDI-DI
05708932156967, 05708932230551, 05708932190480
Basic UDI-DI
570893229758197
Unit of Use DI
05701780103756, 05701780103794, 05701780103763
EMDN Code
A1001030102 One-piece urostomy bags for non-retracted stoma, flat, with tissue cover
Device Class
Class I
Market of Registration
Netherlands
Denmark
Ireland

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 7c4a5568-1c63-45e8-b129-3f68f240c52c 61 fields · synced 22 Oct 2026
  • EUDAMED 05708932230551|570893229758197 61 fields · synced 17 May 2026
  • EUDAMED 05708932190480|570893229758197 61 fields · synced 19 May 2026