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Falco 101

by Siare Enginnering International Group S.p.A. EUDAMED

Active European Union

Ref 980111Model FALCO HOME CARE LINE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80337372615Q2 Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Model / Reference
FALCO HOME CARE LINE, 980111
Primary DI / UDI-DI
08033737261552
Basic UDI-DI
80337372615Q2
Direct Marketing DI
08033737261552
EMDN Code
Z12030103 Pulmonary ventilators for non–hospital use
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000025581

Other devices from Siare Enginnering International Group S.p.A.

See all devices from Siare Enginnering International Group S.p.A. →

Properties

  • Administering Medicine
  • Measuring Function

Other properties (11)

  • 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
  • Incorporates Medicinal Product: No