Skip to content

Smart LEA 1.3

by MAGALDI INNOVA S.r.l. EUDAMED

Active European Union

Ref 1241Model Software di monitoraggio clinico Smartlea

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08055709520009 Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

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
Software di monitoraggio clinico Smartlea, 1241
Primary DI / UDI-DI
08055709520009
Basic UDI-DI
B-08055709520009
EMDN Code
Z12030282 Vital signs monitoring instruments - software accessories
Device Class
Class IIa
Special Device Type
-1192
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027963

From the manufacturer

Manufacturer's product page: SmartLea

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No