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Magnetic Resonance Imaging System
EUDAMEDClass IIa (EU MDR)
Ref 2000Model Supernova OS5
Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- Supernova OS5 EUDAMED2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975312910573 EUDAMED
- Basic UDI-DI
- B-06975312910573 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
- Malta 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 Kuanteng (Liaoning) Medical Devices 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-06975312910573 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kuanteng (Liaoning) Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000010538
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a873f002-6657-40b8-819d-cc31bbe7983b 61 fields · synced Jun 19, 2026