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Spiromix Dm Sico

by SICO Società Italiana Carburo Ossigeno S.p.A. 72 variants

Ref XDSPR31CB01D05000BNA

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805948259SPIX01UL Basic UDI-DI 08059482590068UDI-DIDate26 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Spiromix Dm Sico
Model / Reference
XDSPR31CB01D05000BNA
Primary DI / UDI-DI
08059482590068
Basic UDI-DI
805948259SPIX01UL
Direct Marketing DI
08059482590006
EMDN Code
Z12150185 Spirometry instruments - consumables
Device Class
Class IIb
EU 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

  • 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