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Ostoform Barrier Extender

by Ostoform Limited Ireland EUDAMED

Ref OFA-10010 EMDN A108001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539153622OFA-EXTEK Basic UDI-DIDate26 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  • Withdrawn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 22 Oct 2026

Model / Reference
OFA-10010
Primary DI / UDI-DI
05391536221966
Basic UDI-DI
539153622OFA-EXTEK
EMDN Code
A108001 Rings / bezels / plates for peristomal skin
Device Class
Class I
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
IE-MF-000014357

From the manufacturer

Manufacturer's product page: Ostoform Barrier Extender $39.95

Other devices from Ostoform Limited

See all devices from Ostoform 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 5ceac8f9-db58-4294-a1a6-a6c4458090c4 61 fields · synced 22 Oct 2026