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Spiromix Dm Sico

by SICO Società Italiana Carburo Ossigeno S.p.A. Italy EUDAMED

Ref XDSPR53CB01D04000BNA

EMDN Z12150185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805948259SPIX01UL Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Spiromix Dm Sico
Model / Reference
XDSPR53CB01D04000BNA
Primary DI / UDI-DI
08059482590617
Basic UDI-DI
805948259SPIX01UL
Direct Marketing DI
08059482590563
EMDN Code
Z12150185 Spirometry instruments - consumables
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028343

Other devices from SICO Società Italiana Carburo Ossigeno S.p.A.

See all devices from SICO Società Italiana Carburo Ossigeno S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • CMR Substance
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 3e69555a-7827-45d1-a2b1-4387a6efc5db 61 fields · synced 23 Oct 2026