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Gastrotuss Spray

by Drugs Minerals and Generics Italia S.r.l.

Ref PL305VMModel Spray Orale Lubrificante Lenitivo

Active European Union

CE MDR

Valid until

11 Apr 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803412518TF3779 Basic UDI-DI 08034125187959UDI-DIDate17 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/6038.2 Active Reissued

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    9 Jun 2026
    Expires
    11 Apr 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Spray Orale Lubrificante Lenitivo, PL305VM
Primary DI / UDI-DI
08034125187959
Basic UDI-DI
803412518TF3779
EMDN Code
Q030499 Otology devices - other
Device Class
Class IIb
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
IT-MF-000024945

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    Class IIb

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    Class IIb

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See all devices from Drugs Minerals and Generics Italia S.r.l. →

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