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Direct Digital Radiology System
EUDAMEDClass IIb (EU MDR)
Ref N/AModel 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 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964312881 EUDAMED
- Basic UDI-DI
- 693896431200N7 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
Category: Stationary basic diagnostic x-ray system, digital
Direct Digital Radiology System by Beijing Wandong Medical Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (2)
- EUDAMED ce4cf93a-fe99-48c6-be24-47107e264246-1 61 fields · synced Jun 18, 2026
- EUDAMED ce4cf93a-fe99-48c6-be24-47107e264246-2 61 fields · synced Jun 18, 2026