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Metode

by Ste Pharmaceuticals, S.L.U EUDAMED

Active European Union

Ref PL0032_BB, PLASP004, PL0033_AD, PL0032_AD

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843654262PL00328K 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  • Withdrawn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
Isotonic Sea Water
Nasal Aspirator and Refills
Hypertonic Sea Water
Model / Reference
PL0032_BB, PLASP004, PL0033_AD, PL0032_AD
Primary DI / UDI-DI
07071134125573, 07071134125597, 07071134125764, 07071134125757
Basic UDI-DI
843654262PL00328K, 843654262PL00ASPGC, 843654262PL00338M
EMDN Code
Q030103, R05010399
Device Class
Class IIa
Class I
Market of Registration
Norway

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

Show properties
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