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Direct Digital Radiology System
EUDAMEDClass IIb (EU MDR)
Ref GMDN Code: 37645Model New Oriental 1000U1, New Oriental 1000N1a, New Oriental 1000N2s, New Oriental 1000N5s, New Oriental 1000FC, New Oriental 1000LB, Starview
Identity
- Device Name
- Direct Digital Radiology System EUDAMED
- Model / Reference
- New Oriental 1000U1, New Oriental 1000N1a, New Oriental 1000N2s, New Oriental 1000N5s, New Oriental 1000FC, New Oriental 1000LB, Starview EUDAMEDGMDN Code: 37645 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964312447 EUDAMED06938964312270 EUDAMED06938964312621 EUDAMED06938964312348 EUDAMED
- Basic UDI-DI
- 693896431200N7 EUDAMED
- Direct Marketing DI
- 06938964312447 EUDAMED06938964312270 EUDAMED06938964312621 EUDAMED06938964312348 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Direct Digital Radiology System by Beijing Wandong Medical Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 693896431200N7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Wandong Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014174
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED be57e86c-cd0c-493e-bebd-d178507087c3 61 fields · synced Jul 26, 2026
- EUDAMED f443c869-fe86-4225-8cba-467f8f6868c5 61 fields · synced May 17, 2026
- EUDAMED a589e4c7-69e2-4b36-a6f2-919dc30358fa 61 fields · synced May 17, 2026
- EUDAMED d77e9dcf-2fd0-46a7-8cbb-e237ceed9949 61 fields · synced May 17, 2026