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Vagisil Gel Lubrificante Vaginale

by Combe Incorporated United States EUDAMED

Ref RD-005116

EMDN U0803

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10011509030204 Basic UDI-DIDate7 Nov 2023RegisteredStatusActive

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
Vagisil Lubricant Gel
Model / Reference
RD-005116
Primary DI / UDI-DI
10011509030204
Basic UDI-DI
B-10011509030204
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000024551
Authorised representative
COMBE EUROPA S.L ES-AR-000023377

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 9416df0b-47c8-4ddf-a21c-46d9ddedec06 61 fields · synced 22 Oct 2026