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MedicaVox®

by bitop AG Germany EUDAMED

Ref 38095Model EHT11 EMDN Q0399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-38095HC Basic UDI-DIDate3 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Ectoin® Protect Lozenges Honey Lemon
Model / Reference
EHT11, 38095
Primary DI / UDI-DI
D-38095HC
Basic UDI-DI
B-38095HC
EMDN Code
Q0399 ENT devices - other
Device Class
Class I
Market of Registration
Belgium

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 (1)

  • EUDAMED dbdbf568-3f7c-4367-8751-1e063f7f136e 61 fields · synced 22 Oct 2026