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Saginil Gelis

by Epitech Group SpA Italy EUDAMED

Ref 6404Model 40 mL

EMDN U0803

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80313596021MZ Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Gel vaginale
Model / Reference
40 mL, 6404
Primary DI / UDI-DI
08031359064049
Basic UDI-DI
80313596021MZ
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb
Market of Registration
Lithuania

Manufacturer details

EUDAMED SRN
IT-MF-000031026

Other devices from Epitech Group SpA

See all devices from Epitech Group SpA →

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 08031359064049|80313596021MZ 61 fields · synced 24 Oct 2026