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Epibiot Gel

by Crab Sinergy Srl EUDAMED

Active European Union

Ref VHG005 ITModel VAGINAL GELS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033776702287001J3 Basic UDI-DIDate17 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/5829 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    15 May 2025
    Expires
    14 May 2030

Specification

EUDAMED

Model / Reference
VAGINAL GELS, VHG005 IT
Primary DI / UDI-DI
08033776701316
Basic UDI-DI
8033776702287001J3
Direct Marketing DI
08033776701316
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
IT-MF-000008825

Other devices from Crab Sinergy Srl

See all devices from Crab Sinergy Srl →

Properties

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