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Fl-X Flussimetro C/Umid. Bs O2

by Spencer Italia s.r.l. EUDAMED

Active European Union

Ref FL08319Model Flowmeter with humidifier

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805771123FLOWMETERGROUP4J Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Flowmeter with humidifier, FL08319
Primary DI / UDI-DI
08057711235520
Basic UDI-DI
805771123FLOWMETERGROUP4J
Direct Marketing DI
08057711235520
EMDN Code
R0699 Nebulisation and humidification systems - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027507

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Properties

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