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Puressentiel Respiratoire Spray Nasal Decongestionnant 30 Ml

by Laboratoire Puressentiel Ireland Limited

Ref 6224058

Active European Union

CE MDR CE MDD

Valid until

20 Oct 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Eurofins Product Testing Italy S.r.l.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.25/5954 Date21 Oct 2025IssuedStatusActive expires 20 Oct 2030
European UnionCE/MDD NumberB-3701056801463SU Basic UDI-DI Date25 Apr 2022RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/5954 Active

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    21 Oct 2025
    Expires
    20 Oct 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
Puressentiel Respiratoire Spray Nasal Decongestionnant 30 Ml
PURESSENTIEL® RESPIRATOIRE SPRAY NASAL DECONGESTIONNANT (30ml)
Device Name
Puressentiel® Respiratoire Spray Nasal Decongestionnant
Model / Reference
6224058
Primary DI / UDI-DI
D-3701056801463SU, 03701056801463
Basic UDI-DI
B-3701056801463SU, 37010568RESPIRATOIREVNNG
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class I
Class IIa
EU market of registration
Ireland
France

Manufacturer details

EUDAMED SRN
IE-MF-000015521

From the manufacturer

Manufacturer's product page: Spray Hygiène Nasale Bébé

Other devices from Laboratoire Puressentiel Ireland Limited

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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