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Magnetic Resonance (MR) Systems
EUDAMEDClass IIa (EU MDR)
Ref N/AModel i_Open 0.3T, i_Open 0.36T, i_Open 0.4T, i_Open 0.5T
Identity
- Device Name
- Magnetic Resonance (MR) Systems EUDAMED
- Model / Reference
- i_Open 0.3T, i_Open 0.36T, i_Open 0.4T, i_Open 0.5T EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964321012 EUDAMED
- Basic UDI-DI
- 693896432100N9 EUDAMED
- EMDN Code
- Z11050102 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T EUDAMED
Classification
- Device Class
- Class IIa 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
Magnetic Resonance (MR) Systems by Beijing Wandong Medical Technology Co., Ltd. — Class IIa — 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 | 693896432100N9 | Class IIa | 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 e1bea921-5d99-4184-9784-dc45ea5f164d 61 fields · synced Jul 17, 2026
- EUDAMED e1bea921-5d99-4184-9784-dc45ea5f164d-1 61 fields · synced Jun 10, 2026