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Boccaglio aerosol

by SOPLAST EMILIANA S.r.l. Italy EUDAMED

Ref 302

EMDN R03010380

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805214119DMClasse2a3Z Basic UDI-DIDate6 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 62182 Issued

    Quality assurance EU MDR

    Notified body
    CERTIQUALITY S.r.l. 0546
    Issued
    21 Jan 2026
    Expires
    20 Jan 2031

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dispositivi per Aerosol Che Non Veicolano Farmaci
Model / Reference
302
Primary DI / UDI-DI
08052141190067
Basic UDI-DI
805214119DMClasse2a3Z
Direct Marketing DI
08052141190067
EMDN Code
R03010380 Aerosol therapy systems - accessories
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000025628

Other devices from SOPLAST EMILIANA S.r.l.

See all devices from SOPLAST EMILIANA 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 237dab7e-c31d-4323-9f88-23d4f7730d4d 61 fields · synced 22 Oct 2026