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Ostoform FLOWASSIST Convex Urostomy Pouch

by Ostoform Limited EUDAMED

Active European Union

Ref OFA-10012-L

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539153622OFA-1CBUPQN Basic UDI-DIDate10 Jun 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  • Withdrawn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

Model / Reference
OFA-10012-L
Primary DI / UDI-DI
05391536222147
Unit of Use DI
05391536222116
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000014357

From the manufacturer

Manufacturer's product page: FLOWASSIST Urostomy 2-Piece Pouch $39.95

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