Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- BTI-020 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973833353015 EUDAMED
- Basic UDI-DI
- B-06973833353015 EUDAMED
- EMDN Code
- Z11050101 SECTORAL TOMOGRAPHS (FOR TOMOGRAPHIC EXAMINATIONS OF THE EXTREMITIES) 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-06973833353015 | 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 f0c9cbe9-b61d-41bf-86f0-f98100b8171a 61 fields · synced Aug 1, 2026