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HAI-RadX Suite

by Harrison-AI Medical Pty Ltd EUDAMED

Active European Union

Ref RADXCXR1Model Annalise Container

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G140ANNALISECONTAINERR9 Basic UDI-DIDate5 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Model / Reference
Annalise Container, RADXCXR1
Primary DI / UDI-DI
G140RADXCXR10
Basic UDI-DI
++G140ANNALISECONTAINERR9
EMDN Code
Z11030592 Radiology instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
AU-MF-000010247
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Other devices from Harrison-Ai Medical Pty Ltd

See all devices from Harrison-Ai Medical Pty Ltd →

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