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Audyzen

by Ste Pharmaceuticals, S.L.U Spain EUDAMED

Ref PL0027_100_Soft

EMDN Q03040299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843654262PL00278S Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Isotonic Sea Water Ear Spray
Model / Reference
PL0027_100_Soft
Primary DI / UDI-DI
08436542627146
Basic UDI-DI
843654262PL00278S
EMDN Code
Q03040299 Ear irrigation devices - other
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000144

Other devices from Ste Pharmaceuticals, S.L.U

See all devices from Ste Pharmaceuticals, S.L.U →

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 (1)

  • EUDAMED 6365c2aa-794e-4152-a71d-5337eca749f8 61 fields · synced 22 Oct 2026