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Insufflatore endotimpanico 129

by FASET Fabbrica Apparecchi Scientifici Elettromedicali Termali S.r.l. EUDAMED

Active European Union

Ref 129

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805666680ENTQE Basic UDI-DIDate5 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030114-00 Active

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    23 Dec 2024
    Expires
    22 Dec 2029

Specification

EUDAMED

Device Name
Insufflatore Endotimpanico/ Device for endotympanic insufflation, nebulizer
Model / Reference
129
Primary DI / UDI-DI
08056666800203
Basic UDI-DI
805666680ENTQE
EMDN Code
Z12159002 Aerosol equipment
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000041843

Other devices from FASET Fabbrica Apparecchi Scientifici Elettromedicali Termali 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