Skip to content

Sicca-Gynaedron

by HÄLSA Pharma GmbH EUDAMED

Active European Union

Ref FRT00202

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42517781MD368PPAG Basic UDI-DIDate22 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
FRT00202
Primary DI / UDI-DI
04251778109495
Basic UDI-DI
42517781MD368PPAG
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb
Medical Purpose
The procedure pack consists of a cream for the treatment of vaginal dryness where it is expected to moisturize the dry vagina and to alleviate related symptoms such as itching, burning and pain as well as to regenerate and protect the vaginal environment after infections and a reuseable scaled plastic applicator. Tube and applicator are packed in a folding box.

Manufacturer details

EUDAMED SRN
DE-PR-000043992

Other devices from HÄLSA Pharma GmbH

See all devices from HÄLSA Pharma GmbH →

Properties

Other properties (1)

  • Sterile: No