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Ftes

by Fomema Iot Sdn.bhd EUDAMED

Active European Union

Ref DXR-MEDICAL-FTES-AModel FTES

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955101846FTESGR Basic UDI-DIDate14 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  • Withdrawn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 Teleradiology Solution (Ftes)
Model / Reference
FTES, DXR-MEDICAL-FTES-A
Primary DI / UDI-DI
09551018460009
Basic UDI-DI
955101846FTESGR
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

  • Faix

    Class I

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No