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Smart Checker

by IMS GIOTTO S.p.A. Italy EUDAMED

Ref 28350Model SMART CHECKER

EMDN W05019099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805697736SMCTR Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SMART CHECKER, 28350
Primary DI / UDI-DI
08056977360359
Basic UDI-DI
805697736SMCTR
Direct Marketing DI
08056977360359
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
IT-MF-000025920

Other devices from Ims Giotto S.P.A.

See all devices from Ims Giotto S.P.A. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08056977360359|805697736SMCTR 61 fields · synced 24 Oct 2026