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Solimar

by Ste Pharmaceuticals, S.L.U Spain EUDAMED

Ref PL0032_BB, PL0141_120_Soft, PL0112_120_Medium, PL0033_BB EMDN Q030103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843654262PL00328K 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  • Withdrawn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European Union — CE/MDR Withdrawn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
Isotonic Sea Water
Isotonic Sea Water Nasal Spray with Aloe Vera and Hyaluronic Acid
Hypertonic Sea Water with Aloe Vera and Eucalyptus
Hypertonic Sea Water
Model / Reference
PL0032_BB, PL0141_120_Soft, PL0112_120_Medium, PL0033_BB
Primary DI / UDI-DI
08436617644146, 08436617644207, 08436617644184, 08436617644160
Basic UDI-DI
843654262PL00328K, 843654262PL01418R, 843654262PL01128J, 843654262PL00338M
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 (4)

  • EUDAMED e0a6ba71-41d2-4b23-9429-4588171e3bbf 61 fields · synced 24 Oct 2026
  • EUDAMED 08436617644207|843654262PL01418R 61 fields · synced 17 May 2026
  • EUDAMED 08436617644184|843654262PL01128J 61 fields · synced 17 May 2026
  • EUDAMED 08436617644160|843654262PL00338M 61 fields · synced 17 May 2026