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Hydralin ConfortVaginal

by bitop AG Germany EUDAMED

Ref 38069Model EIC01 EMDN U0899

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-DE-MF-000006543-38069UU Basic UDI-DIDate19 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-DE-MF-000006543-38069UU Basic UDI-DIDate19 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  • Withdrawn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 24 Oct 2026

Device Name
Ectoin® Vaginal Gel
Ectoin Vaginal Gel
Model / Reference
EIC01, 38069
Primary DI / UDI-DI
D-DE-MF-000006543-38069UU, 04260265220278
Basic UDI-DI
B-DE-MF-000006543-38069UU, 426026522EICPP2A
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class I
Market of Registration
France
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 e232c68c-7d0f-4afe-80e1-fad3841fd9ce 61 fields · synced 24 Oct 2026
  • EUDAMED 04260265220278|426026522EICPP2A 61 fields · synced 3 Aug 2026