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Aluneb Gel Nasal

by Sakura Italia Srl

Ref SK016300ES1Model ALUNEB NASAL GEL

Active European Union

CE MDR CE MDD

Valid until

17 Jul 2029

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-ITMF9937SK016300ES1WS Basic UDI-DI Date30 Sep 2026RegisteredStatusActive
European UnionCE/MDD NumberB-ITMF9937SK016300ES1WS Basic UDI-DI Date30 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.24/5566.2 Active Reissued

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    13 May 2025
    Expires
    17 Jul 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Aluneb Nasal Gel
Model / Reference
ALUNEB NASAL GEL, SK016300ES1
Primary DI / UDI-DI
D-ITMF9937SK016300ES1WS, 08055348700879
Basic UDI-DI
B-ITMF9937SK016300ES1WS, 805534870AG0162V
Direct Marketing DI
08055348700879
EMDN Code
Q030199 Nasopharyngeal devices - other
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009937

Other devices from Sakura Italia Srl

See all devices from Sakura Italia Srl →

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