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Digital X-Ray Radiography System

by Kuanteng (Liaoning) Medical Devices Co., Ltd. 2 variants

Ref 2001Model RayNova DRsc5

Active European Union

CE MDD

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/MDD NumberB-06975312910634 Basic UDI-DI 06975312910634UDI-DIDate15 May 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Digital X-Ray Radiography System
Model / Reference
RayNova DRsc5, 2001
Primary DI / UDI-DI
06975312910634
Basic UDI-DI
B-06975312910634
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
Device Class
Class IIb
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
CN-MF-000010538
Authorised representative
Lotus NL B.V. NL-AR-000000121

Related devices

Category: Stationary basic diagnostic x-ray system, digital

Other devices from Kuanteng (Liaoning) Medical Devices Co., Ltd.

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No