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Aurega Skin Barrier Wipe

by Cortmed International Limited Ireland EUDAMED

Ref SBW30 EMDN A108004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539154384SBWP5 Basic UDI-DIDate17 Dec 2024RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Skin Barrier Wipe
Model / Reference
SBW30
Primary DI / UDI-DI
05391543842475
Basic UDI-DI
539154384SBWP5
Direct Marketing DI
05391543842475
EMDN Code
A108004 Protective films / sprays for peristomal skin
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000002464

From the manufacturer

Manufacturer's product page: see all

Other devices from Cortmed International Limited

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 (1)

  • EUDAMED a2fade77-2d37-4c6f-a8c2-5d5b16f75a35 61 fields · synced 22 Oct 2026