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OPTISANA Hypertonic Nasal Spray

by Ste Pharmaceuticals, S.L.U EUDAMED

Active European Union

Ref PL0033_AD

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843654262PL00338M Basic UDI-DIDate28 Apr 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  • Withdrawn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

Device Name
Hypertonic Sea Water
Model / Reference
PL0033_AD
Primary DI / UDI-DI
04062981033091
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
ES-MF-000000144

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