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Medical X-ray Radiography Unit
EUDAMEDClass IIb (EU MDR)
Ref New Oriental 1000UERef New Oriental 1000CERef New Oriental 1000MCRef New Oriental 1000DB
Identity
- Trade Name
- Medical X-ray Radiography Unit EUDAMED
- Device Name
- Medical X-ray Radiography Unit EUDAMED
- Model / Reference
- New Oriental 1000UE EUDAMEDNew Oriental 1000CE EUDAMEDNew Oriental 1000MC EUDAMEDNew Oriental 1000DB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964312065 EUDAMED06938964312034 EUDAMED06938964312058 EUDAMED06938964312041 EUDAMED
- Basic UDI-DI
- B-06938964312065 EUDAMEDB-06938964312034 EUDAMEDB-06938964312058 EUDAMEDB-06938964312041 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medical X-ray Radiography Unit by Beijing Wandong Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06938964312065 | 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 f40b0b3c-236a-4987-9e57-697e0df5a849 61 fields · synced Jul 31, 2026
- EUDAMED 7cd95255-5532-422d-b87f-cc1bb9be8d8c 61 fields · synced May 18, 2026
- EUDAMED 76739944-6ba3-4fb4-93e2-f9581563334a 61 fields · synced May 18, 2026
- EUDAMED 3f573593-c404-4412-ad60-bf35c8b4254b 61 fields · synced May 18, 2026