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Oralieve Gel

by Europharma Concepts Ltd Ireland EUDAMED

Ref 61ORMGML12

EMDN V9017

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-61ORMGML12VQ Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Oralieve Gel
Model / Reference
61ORMGML12
Primary DI / UDI-DI
D-61ORMGML12VQ
Basic UDI-DI
B-61ORMGML12VQ
EMDN Code
V9017 Oral administration preparations not included in other classes
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000024843

Other devices from Europharma Concepts Ltd

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 9f6d24e2-041c-48b8-8cf0-856bef0fdffe 61 fields · synced 22 Oct 2026