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Balanil Gelis

by Epitech Group SpA Italy EUDAMED

Ref 6402Model 40 ml

EMDN U99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80313596011MW Basic UDI-DIDate22 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Gel intimo
Model / Reference
40 ml, 6402
Primary DI / UDI-DI
08031359064025
Basic UDI-DI
80313596011MW
EMDN Code
U99 Devices for urogenital system - other
Device Class
Class IIa
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 a772c5b6-8188-437b-a23f-078d057e8865 61 fields · synced 23 Oct 2026