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Allengers

by Allengers Medical Systems Limited 26 variants

Ref AMSL/DMR/UM/FD 001Model Digix FDX

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89041397DIGIXFDX7N Basic UDI-DI 08904139700232UDI-DIDate3 Mar 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
High Frequency X-Ray Machine with Digital Radiography (Digital detector Based)
Model / Reference
Digix FDX, AMSL/DMR/UM/FD 001
Primary DI / UDI-DI
08904139700232
Basic UDI-DI
89041397DIGIXFDX7N
Direct Marketing DI
08904139700232
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
Device Class
Class IIb
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
IN-MF-000032921
Authorised representative
Easy Medical Device CommV BE-AR-000011902

Other devices from Allengers Medical Systems Limited

See all devices from Allengers Medical Systems Limited →

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