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Bisolduo® 2.0

by bitop AG Germany EUDAMED

Ref 35112Model EHT11 EMDN Q0399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-DE-MF-000006543-35112TF Basic UDI-DIDate19 May 2026RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Device Name
Ectoin® Protect Lozenges Honey Lemon
Model / Reference
EHT11, 35112
Primary DI / UDI-DI
D-DE-MF-000006543-35112TF
Basic UDI-DI
B-DE-MF-000006543-35112TF
EMDN Code
Q0399 ENT devices - other
Device Class
Class I
Market of Registration
Finland

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 6ea868de-92e6-45be-885f-fbbcd965c25c 61 fields · synced 23 Oct 2026