Skip to content

Faix

by Fomema Iot Sdn.bhd EUDAMED

Active European Union

Ref DXR-MEDICAL-FAIX-AModel FAIX

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955101846FAIXEG Basic UDI-DIDate20 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
FOMEMA Artificial Intelligence X-ray (FAIX)
Model / Reference
FAIX, DXR-MEDICAL-FAIX-A
Primary DI / UDI-DI
09551018460016
Basic UDI-DI
955101846FAIXEG
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
MY-MF-000030521
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Fomema Iot Sdn.bhd

  • Ftes

    Class I

Properties

Other properties (13)

  • 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No