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SofiMer FRESH

by Ste Pharmaceuticals, S.L.U Spain EUDAMED

Ref PL0112_120_Medium EMDN Q030103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843654262PL01128J 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 24 Oct 2026

Device Name
Hypertonic Sea Water with Aloe Vera and Eucalyptus
Model / Reference
PL0112_120_Medium
Primary DI / UDI-DI
08436617646485
Basic UDI-DI
843654262PL01128J
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa

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 d224c5c0-26b8-45ab-887b-c74698b18c49 61 fields · synced 24 Oct 2026