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Ectoin® Vaginal Gel

by bitop AG Germany EUDAMED

Ref 32996Model EIC01 EMDN U0899

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-DE-MF-000006543-32996V2 Basic UDI-DIDate13 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-DE-MF-000006543-32996V2 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Ectoin Vaginal Gel
Model / Reference
EIC01, 32996
Primary DI / UDI-DI
D-DE-MF-000006543-32996V2, 04260265221213
Basic UDI-DI
B-DE-MF-000006543-32996V2, 426026522EICPP2A
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class I
Market of Registration
Germany
Medical Purpose
Intended Purpose: mMoisturizing gel for the relief of vaginal dryness/vaginal atrophy

Manufacturer details

EUDAMED SRN
DE-MF-000006543

Other devices from bitop AG

See all devices from bitop AG →

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 (2)

  • EUDAMED b477bb04-5c60-4bb3-91ea-998b0611eab2 61 fields · synced 22 Oct 2026
  • EUDAMED 04260265221213|426026522EICPP2A 61 fields · synced 19 Jun 2026