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Mobile C-arm X-ray System
EUDAMEDClass IIb (EU MDR)
Ref N/AModel Hypernova-Y Plus, Flexion
Identity
- Device Name
- Mobile C-arm X-ray System EUDAMED
- Model / Reference
- Hypernova-Y Plus, Flexion EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964324020 EUDAMED
- Basic UDI-DI
- 693896431401NK EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC 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 C-arm 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 | 693896431401NK | 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 f113947e-641f-4122-90ff-fb4ecf0a6594-1 61 fields · synced Jun 20, 2026
- EUDAMED f113947e-641f-4122-90ff-fb4ecf0a6594-2 61 fields · synced Jun 20, 2026