Skip to content

Sterimar Nasal Hygiene 50 ml

by Sofibel

Ref 3331300097221, 03331300097221Model STÉRIMAR

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number333130STE-SPRAYAJ Basic UDI-DI 03331300097221UDI-DIDate24 Nov 2023RegisteredStatusActive
European UnionCE/MDR Number333130STE-SPRAYAJ Basic UDI-DI 03331300097221UDI-DIDate24 Nov 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
Sterimar Nasal Hygiene 50 ml
Stérimar HYGIENA NOSA 50 mL
Stérimar Nose Hygiene 50 mL
Device Name
Stérimar
Stérimar Breathe Easy Daily 50 mL Stérimar Hygiène du Nez 50 mL Stérimar Nose Hygiene 50 mL Stérimar NOSNI HYGIENA 50 mL Stérimar HYGIENA NOSA 50 mL
Isotonic Nasal Irrigation Solution Device Group
Model / Reference
3331300097221, STÉRIMAR, 03331300097221
Primary DI / UDI-DI
03331300097221
Basic UDI-DI
333130STE-SPRAYAJ, B-03331300097221, 333130-STE-ISONIS-XY
Direct Marketing DI
03331300097221
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000003192

Other devices from Sofibel

See all devices from Sofibel →

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