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Otosan

by Otosan Srl Italy EUDAMED

Ref 1000101128, 1000018373, 1000013212 EMDN Q0399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number8016887CONES22 Basic UDI-DIDate28 Mar 2022RegisteredStatusActive
European UnionCE/MDR Number8016887CONES22 Basic UDI-DIDate28 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Otosan Cono per L'igiene Dell'orecchio
Fortuss
Nasal Spray Forte
Model / Reference
1000101128, 1000018373, 1000013212
Primary DI / UDI-DI
08016887000011, D-FortussHR, D-NasalSprayB9
Basic UDI-DI
8016887CONES22, B-FortussHR, B-NasalSprayB9
Unit of Use DI
08016887000318
EMDN Code
Q0399, V9017, Q030199
Device Class
Class I
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000017617

Other devices from Otosan Srl

See all devices from Otosan Srl →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (3)

  • EUDAMED 12fa2a31-592b-4578-bacb-fcd45de88fc2 61 fields · synced 22 Oct 2026
  • EUDAMED D-FORTUSSHR|B-FORTUSSHR 61 fields · synced 17 May 2026
  • EUDAMED D-NASALSPRAYB9|B-NASALSPRAYB9 61 fields · synced 19 May 2026