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Nebulair aerosol (S4-001)

by Enable Innovations SRL EUDAMED

Active European Union

Ref 050386Model Soluzione inalatoria S4

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80540851211NL Basic UDI-DIDate8 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030179-00 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    23 Mar 2026
    Expires
    22 Mar 2031

Specification

EUDAMED

Device Name
Soluzione inalatoria S4
Model / Reference
Soluzione inalatoria S4, 050386
Primary DI / UDI-DI
08054085121299
Basic UDI-DI
80540851211NL
EMDN Code
Q030199 Nasopharyngeal devices - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026066

Other devices from Enable Innovations SRL

See all devices from Enable Innovations SRL →

Properties

Show 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