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Magnetic Resonance (MR) Systems
EUDAMEDClass IIa (EU MDR)
Ref N/AModel i_Vision 1.5T Plus, i_Space 1.5T, i_Space 1.5T Plus, i_Space 1.5T Pro, i_Field 1.5T, i_Field 1.5T Plus, i_Field 1.5T Pro, i_Vision 1.5T, i_Vision 1.5T Pro, i_Scope, i_Scope X, i_Scope XTModel i_Vision 1.5T Plus, i_Vision 1.5T, i_Vision 1.5T Pro, i_Vision70 1.5T, i_Vision70 1.5T Plus, i_Vision70 1.5T Pro
Identity
- Device Name
- Magnetic Resonance (MR) Systems EUDAMED
- Model / Reference
- i_Vision 1.5T Plus, i_Space 1.5T, i_Space 1.5T Plus, i_Space 1.5T Pro, i_Field 1.5T, i_Field 1.5T Plus, i_Field 1.5T Pro, i_Vision 1.5T, i_Vision 1.5T Pro, i_Scope, i_Scope X, i_Scope XT EUDAMEDN/A EUDAMEDi_Vision 1.5T Plus, i_Vision 1.5T, i_Vision 1.5T Pro, i_Vision70 1.5T, i_Vision70 1.5T Plus, i_Vision70 1.5T Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964322149 EUDAMED
- Basic UDI-DI
- 693896432200NE EUDAMED
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T 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 | 693896432200NE | 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 0f243060-319f-4a16-b7ed-2f209536d6c7 61 fields · synced Jul 24, 2026
- EUDAMED 0f243060-319f-4a16-b7ed-2f209536d6c7-1 61 fields · synced Jun 10, 2026