← Back to catalogue
Magnetic Resonance Imaging System
EUDAMEDClass IIa (EU MDR)
Ref /Model Bstar-070
Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- Bstar-070 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973833353060 EUDAMED
- Basic UDI-DI
- B-06973833353060 EUDAMED
- EMDN Code
- Z11050103 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY GREATER THAN 0.5T 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
Magnetic Resonance Imaging System by Shenzhen Basda Medical Apparatus Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06973833353060 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 10cf5009-f6d0-4ea9-9453-d5e4a00a202f 61 fields · synced Jul 9, 2026