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Ectifem żel

by bitop AG

Ref 30751Model EIC01

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number426026522EICPP2A Basic UDI-DI Date15 Sep 2025RegisteredStatusActive
European UnionCE/MDR Number426026522EICPP2A Basic UDI-DI Date15 Sep 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device Name
Ectoin Vaginal Gel
Ectoin® Vaginal Gel
Model / Reference
EIC01, 30751
Primary DI / UDI-DI
04260265220247, D-DE-MF-000006543-30751TL
Basic UDI-DI
426026522EICPP2A, B-DE-MF-000006543-30751TL
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class I
EU market of registration
Poland
Medical Purpose
Intended Purpose: mMoisturizing gel for the relief of vaginal dryness/vaginal atrophy

Manufacturer details

EUDAMED SRN
DE-PR-000024709

Other devices from bitop AG

See all devices from bitop AG →

Properties

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