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Oticlean Spray

by Ste Pharmaceuticals, S.L.U EUDAMED

Withdrawn Not intended for the EU market

Ref PL0135

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843654262PL01358W Basic UDI-DIDate28 Apr 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Ear Spray Solution for Cerumen Plugs
Model / Reference
PL0135
Primary DI / UDI-DI
08436617646447

Manufacturer details

EUDAMED SRN
ES-MF-000000144

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