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Fidhalo®

by bitop AG Germany EUDAMED

Ref 37041Model EIL07

EMDN R060203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-DE-MF-000006543-37041TX Basic UDI-DIDate16 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Ectoin® Inhalation Solution
Model / Reference
EIL07, 37041
Primary DI / UDI-DI
D-DE-MF-000006543-37041TX
Basic UDI-DI
B-DE-MF-000006543-37041TX
EMDN Code
R060203 Inhalation therapy humidification liquids
Device Class
Class IIa
Market of Registration
Italy

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
  • Sterile
Other properties (10)
  • 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 aa51efc2-34fe-4292-88a2-2481b4569bae 61 fields · synced 22 Oct 2026