Magnetic Resonance (MR) Systems
by Beijing Wandong Medical Technology Co., Ltd. China EUDAMED
Ref N/AModel 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_Scope, i_Scope X, i_Scope XT
EMDN Z11050104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number693896432800PC | Date20 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Magnetic Resonance (MR) Systems
- Model / Reference
- 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_Scope, i_Scope X, i_Scope XT, N/A
- Primary DI / UDI-DI
- 06938964329025
- Basic UDI-DI
- 693896432800PC
- EMDN Code
- Z11050104 Closed magnet MRI scanners with magnetic field less than or equal to 2t
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000014174
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Beijing Wandong Medical Technology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 3e1256c4-6573-42e2-bdac-844c45259500-1