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Orizon Smart Form Super

by Ontex BV Belgium EUDAMED

Ref OID91371920Model Heavy Inco EMDN T04010102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414874HeavyIncoG5 Basic UDI-DIDate30 Apr 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  • Withdrawn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
Heavy Incontinence Devices
Model / Reference
Heavy Inco, OID91371920
Primary DI / UDI-DI
05414874019436
Basic UDI-DI
5414874HeavyIncoG5
EMDN Code
T04010102 Shaped incontinence nappies
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
BE-MF-000003544

Other devices from Ontex BV

See all devices from Ontex BV →

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 b132ba24-b71a-4c3e-bb0d-8a6eea81662e 61 fields · synced 22 Oct 2026