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Cerucalm

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

Ref FR016VMModel Soluzione Otologica

EMDN Q030499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803412518TF0974 Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/6035.1 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    27 Mar 2026
    Expires
    11 Apr 2029

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Soluzione Otologica, FR016VM
Primary DI / UDI-DI
08034125187904
Basic UDI-DI
803412518TF0974
EMDN Code
Q030499 Otology devices - other
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
IT-MF-000024945

Other devices from Drugs Minerals and Generics Italia S.r.l.

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

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 08034125187904|803412518TF0974 61 fields · synced 24 Oct 2026