← Back to catalogue
Magnetic Resonance Imaging System
EUDAMEDClass IIa (EU MDR)
Ref 2000Model Supernova C5Ref Z11050104Model Supernova 1.5TModel Supernova 516W
Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- 2000 EUDAMEDSupernova C5 EUDAMEDSupernova 1.5T EUDAMEDZ11050104 EUDAMEDSupernova 516W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975312910016 EUDAMED06975312910030 EUDAMED06975312910474 EUDAMED06975312910559 EUDAMED06975312910580 EUDAMED
- Basic UDI-DI
- 697531292000JL EUDAMEDB-06975312910016 EUDAMEDB-06975312910559 EUDAMEDB-06975312910580 EUDAMED
- Direct Marketing DI
- 06975312910016 EUDAMED06975312910030 EUDAMED06975312910474 EUDAMED
- EMDN Code
- Z11050102 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T EUDAMEDZ11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697531292000JL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697531292000JL | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kuanteng (Liaoning) Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000010538
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 8a5638ca-d112-4a32-98f6-b547a8c2437c 61 fields · synced Oct 5, 2026
- EUDAMED ac4d2c3b-374b-494d-be92-a29d0aca3490 61 fields · synced May 19, 2026
- EUDAMED 80252350-5c28-4764-b5d4-4fd6e2f81ad4 61 fields · synced May 19, 2026
- EUDAMED f2366d2b-cf6d-433d-be23-2af1d334a007 61 fields · synced Jun 19, 2026
- EUDAMED f230a3eb-3625-42e4-99b2-d5935d95f90f 61 fields · synced Jul 19, 2026
- EUDAMED d47e3b77-4a51-4d0c-872b-8a7766efa5df 61 fields · synced Jul 21, 2026