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Otowaxol Combi

by HÄLSA Pharma GmbH EUDAMED

Active European Union

Ref 3002404Model Otowaxol

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42517781MD394PPAH Basic UDI-DIDate5 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Otowaxol, 3002404
Primary DI / UDI-DI
04251778112174
Basic UDI-DI
42517781MD394PPAH
EMDN Code
Q030499 Otology devices - other
Device Class
Class IIa
Medical Purpose
Otowaxol is a solution intended for instillation into the ear for softening the earwax (cerumen). The softened earwax is then flushed out with lukewarm water removing the excess of earwax and earwax plugs.

Manufacturer details

EUDAMED SRN
DE-PR-000043992

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Properties

Other properties (1)

  • Sterile: No