← Back to catalogue
Digital X-Ray Radiography System
EUDAMEDClass IIb (EU MDR)
Ref 2002Ref 2001Model RayNova DRsc5Model RayNova DRmc
Identity
- Device Name
- Digital X-Ray Radiography System EUDAMED
- Model / Reference
- 2002 EUDAMEDRayNova DRsc5 EUDAMED2001 EUDAMEDRayNova DRmc EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975312910535 EUDAMED06975312910467 EUDAMED06975312910528 EUDAMED06975312910634 EUDAMED06975312910597 EUDAMED
- Basic UDI-DI
- 697531292002JQ EUDAMEDB-06975312910634 EUDAMEDB-06975312910597 EUDAMED
- Direct Marketing DI
- 06975312910535 EUDAMED06975312910467 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Digital X-Ray Radiography System by Kuanteng (Liaoning) Medical Devices Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, digital.
- EXSYS DEXi — Drtech Corp. · Class II
- DX-D 400 — Agfa Corp. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- CARESTREAM DRX-EVOLUTION — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- iDR603V-110 — YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD. · Class IIb
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697531292002JQ | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697531292002JQ | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kuanteng (Liaoning) Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000010538
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 7f31e80a-71e0-401e-a357-417996b722cf 61 fields · synced Sep 18, 2026
- EUDAMED a76dbbcf-e7df-4f4d-89f8-cb0c1025f173 61 fields · synced May 17, 2026
- EUDAMED d664b93c-5ff2-491a-b31a-9211a3a25dba 61 fields · synced May 19, 2026
- EUDAMED 503be7bc-112b-4a09-baa2-8f9a27e82a86 61 fields · synced Jul 21, 2026
- EUDAMED e8e80a4e-fa73-4e04-bcba-74791ed2d451 61 fields · synced Jul 29, 2026