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Mascherina nasale piccola

by SOPLAST EMILIANA S.r.l. Italy EUDAMED

Ref 221, 220 EMDN R03010380

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805214119DMClasse2a3Z Basic UDI-DIDate6 Feb 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  • Withdrawn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)
  • 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

Trade Name
Mascherina nasale piccola
Mascherina nasale
Device Name
Dispositivi per Aerosol Che Non Veicolano Farmaci
Model / Reference
221, 220
Primary DI / UDI-DI
08052141190043, 08052141190036
Basic UDI-DI
805214119DMClasse2a3Z
Direct Marketing DI
08052141190043
08052141190036
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 (2)

  • EUDAMED 3b5abd20-31de-442a-a203-7b2ae280e533 61 fields · synced 22 Oct 2026
  • EUDAMED 08052141190036|805214119DMCLASSE2A3Z 61 fields · synced 19 May 2026