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Nisita® lavage nasal isotonique micro-diffusion

by Yslab

Ref PFNIS_ISO_125NLModel Nasal spray

Active European Union

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-PFNIS_ISO_125NL6K Basic UDI-DI D-PFNIS_ISO_125NL6KUDI-DIDate29 Jul 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Nisita® neusspoeling isotoon micro-diffusion / Nisita® lavage nasal isotonique micro-diffusion / Nisita® isotonische nasenspülung mikrodiffusion
Model / Reference
Nasal spray, PFNIS_ISO_125NL
Primary DI / UDI-DI
D-PFNIS_ISO_125NL6K
Basic UDI-DI
B-PFNIS_ISO_125NL6K
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
FR-MF-000001197

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Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No