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Assura

by Coloplast A/S Denmark EUDAMED

Ref 128480 EMDN A1002010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893229760994 Basic UDI-DIDate12 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Assura/Alterna (Original) ostomy baseplate
Model / Reference
128480
Primary DI / UDI-DI
05701780607360, 05701780733601
Basic UDI-DI
570893229760994
Unit of Use DI
05701780091145, 05701780091015
EMDN Code
A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
Device Class
Class I
Market of Registration
Austria
Sweden

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 dd988ac8-49fe-4ea7-84ca-fc29d90314cd 61 fields · synced 25 Oct 2026
  • EUDAMED 05701780733601|570893229760994 61 fields · synced 19 May 2026