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SIRscan® ORION

by Intelligence Artificielle Applications France EUDAMED

Ref 100007

EMDN W0203010180

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number366662810004DU Basic UDI-DIDate25 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
100007
Primary DI / UDI-DI
03666628002634
Basic UDI-DI
366662810004DU
Direct Marketing DI
03666628002634
EMDN Code
W0203010180 Antibiotic susceptibility analysers - hardware accessories
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000021688

From the manufacturer

Manufacturer's product page: SIRscan Orion

Other devices from Intelligence Artificielle Applications

See all devices from Intelligence Artificielle Applications →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED cf7e8338-beb0-490f-b9a0-d1841f748ad3 61 fields · synced 22 Oct 2026