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Digital Radiography and Fluoroscopy System
EUDAMEDClass IIb (EU MDR)
Ref GMDN Code: 37679Model DRF-6A, DRF-7B, DRF-8B, DRF-8PRO
Identity
- Device Name
- Digital Radiography and Fluoroscopy System EUDAMED
- Model / Reference
- DRF-6A, DRF-7B, DRF-8B, DRF-8PRO EUDAMEDGMDN Code: 37679 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964313222 EUDAMED06938964313260 EUDAMED06938964313208 EUDAMED
- Basic UDI-DI
- 693896431300NC EUDAMED
- Direct Marketing DI
- 06938964313222 EUDAMED06938964313260 EUDAMED06938964313208 EUDAMED
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES 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
Digital Radiography and Fluoroscopy 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 | 693896431300NC | 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 (3)
- EUDAMED b804cc9f-4986-41ab-82c9-8c840c521fe1 61 fields · synced Jul 13, 2026
- EUDAMED c60e4487-f697-4b52-a48c-e3810644b58b 61 fields · synced May 16, 2026
- EUDAMED e4792805-a2ba-4b59-8bd3-5bf30b8b49bd 61 fields · synced May 19, 2026