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Tonimer Isotonic Baby Flaconcini Monodose

by ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche 6 variants

Ref I48V03590Model TONIMER FLACONCINI MONODOSE

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805044485100020072 Basic UDI-DI 08058031944239UDI-DIDate29 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.24/5367 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  • Withdrawn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 FLACONCINI MONODOSE, I48V03590
Primary DI / UDI-DI
08058031944239
Basic UDI-DI
805044485100020072
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIb
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
IT-MF-000027942

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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