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Igea Reader

by A.S.T. s.r.l. Italy EUDAMED

Ref IGEA READER - NEMESYS SMART-POCTModel IGEA READER

EMDN W0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805384180IGEAREADERV2 Basic UDI-DIDate1 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Igea Reader
Model / Reference
IGEA READER, IGEA READER - NEMESYS SMART-POCT
Primary DI / UDI-DI
80538418002256
Basic UDI-DI
805384180IGEAREADERV2
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029421

Other devices from A.S.T. s.r.l.

See all devices from A.S.T. s.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 86695aca-de2b-41e0-8e12-484630783350 61 fields · synced 22 Oct 2026