Skip to content

Assura

by Coloplast A/S EUDAMED

Active European Union

Ref 2833

Regulatory status

as of 27 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  • Withdrawn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

Device Name
Assura/Alterna (Original) ostomy baseplate
Model / Reference
2833
Primary DI / UDI-DI
05701780465618, 05701780818322, 05701780847278, 05701780842426, 05701780842488
Basic UDI-DI
570893229760994
Unit of Use DI
05701780026253, 05701780026246, 05701780026024, 05708932966078, 05701780026383
EMDN Code
A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
Device Class
Class I
Market of Registration
Ireland
Denmark
Netherlands
Germany
Liechtenstein

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

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