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Magnetic Resonance Imaging System
EUDAMEDClass IIa (EU MDR)
Ref /Model Bstar-150
Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- Bstar-150 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973833353077 EUDAMED
- Basic UDI-DI
- B-06973833353077 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
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Full-body MRI system, superconducting magnet
Magnetic Resonance Imaging System by Shenzhen Basda Medical Apparatus Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973833353077 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Basda Medical Apparatus Co., Ltd.
- EUDAMED SRN
- CN-MF-000016596
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f3f138f4-5250-41a6-abd6-b9c46d3a81fa 61 fields · synced Jul 9, 2026