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CanesHydra™

by bitop AG

Ref 38089, 38081Model EIC01

Active European Union

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 NumberB-DE-MF-000006543-38089V2 Basic UDI-DI Date23 Feb 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Ectoin® Vaginal Gel
Ectoin Vaginal Gel
Model / Reference
EIC01, 38089, 38081
Primary DI / UDI-DI
D-DE-MF-000006543-38089V2, 04260265221350, D-DE-MF-000006543-38081UJ, 04260265221329
Basic UDI-DI
B-DE-MF-000006543-38089V2, 426026522EICPP2A, B-DE-MF-000006543-38081UJ
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class I
EU market of registration
Romania
Slovenia
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

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