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Tonimer Panthexyl Spray

by ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche 4 variants

Ref I48V02340, I48V03510, I48V02350Model TONIMER SPRAY NASALE

Active European Union

CE MDR

Valid until

4 Feb 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80504448510001006V Basic UDI-DI Date5 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.24/5368 Active

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    5 Feb 2024
    Expires
    4 Feb 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
TONIMER SPRAY NASALE, I48V02340, I48V03510, I48V02350
Primary DI / UDI-DI
08055510241551, 08058031944147, 08055510241544
Basic UDI-DI
80504448510001006V
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
EU market of registration
Italy
Romania

Manufacturer details

EUDAMED SRN
IT-MF-000027942

Other devices from ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche

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Properties

  • Sterile

Other properties (12)

  • 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