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Ostoform Moldable Seal with FLOWASSIST Protection

by Ostoform Limited EUDAMED

Withdrawn No longer placed on the EU market

Ref OFA-M-S2

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539153622OFAKP Basic UDI-DIDate18 Jan 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
FLOWASSIST Seal
Model / Reference
OFA-M-S2
Primary DI / UDI-DI
05391536220143
Basic UDI-DI
539153622OFAKP
Unit of Use DI
05391536220068
EMDN Code
A108001 Rings / bezels / plates for peristomal skin
Device Class
Class I

Manufacturer details

EUDAMED SRN
IE-MF-000014357

From the manufacturer

Manufacturer's product page: FLOWASSIST Seal

Other devices from Ostoform Limited

See all devices from Ostoform Limited →

Properties

Show 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