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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 XT
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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964322071 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
Category: Full-body MRI system, superconducting magnet
Magnetic Resonance (MR) Systems by Beijing Wandong Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Full-body MRI system, superconducting magnet.
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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 9f9b58a4-11a3-49f8-8e93-15af1e75380c 61 fields · synced Jun 18, 2026
- EUDAMED 9f9b58a4-11a3-49f8-8e93-15af1e75380c-1 61 fields · synced Jun 9, 2026