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Mobile Digital Radiography X-ray System
EUDAMEDClass IIb (EU MDR)
Ref N/AModel M50-1A, M800-1E, M880, M40-1, M40-1A
Identity
- Trade Name
- Mobile Digital Radiography X-ray System EUDAMED
- Device Name
- Mobile Radiographic Unit EUDAMED
- Model / Reference
- M50-1A, M800-1E, M880, M40-1, M40-1A EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964315011 EUDAMED
- Basic UDI-DI
- 693896431500NN EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS 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
Mobile Digital Radiography X-ray 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 | 693896431500NN | 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 f3a032c0-9613-4fdc-83e8-362415f7379e 61 fields · synced Jun 17, 2026
- EUDAMED f3a032c0-9613-4fdc-83e8-362415f7379e-1 61 fields · synced Jun 9, 2026