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X-ray equipment for computed tomography

by KuanTeng (Beijing) Medical Technology Co., Ltd 2 variants

Ref 3000Model Quantum CT Q560a

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6977998783000QM Basic UDI-DI Date30 Jul 2026RegisteredStatusActive

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  • Withdrawn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
X-ray equipment for computed tomography
Model / Reference
Quantum CT Q560a, 3000
Primary DI / UDI-DI
06977998780013, 06977998780020
Basic UDI-DI
6977998783000QM
Direct Marketing DI
06977998780013
06977998780020
EMDN Code
Z11030603 Computed tomographs - 16 layers or more but less than 64 layers
Device Class
Class IIb
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
CN-MF-000045027
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from KuanTeng (Beijing) Medical Technology Co., 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