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Magnetic Resonance Imaging System
EUDAMEDClass IIa (EU MDR)
Ref SuperMark 1.5TRef ASM-030PIII(OPENMARK III)Ref ASM-050P(OPENMARK 5000)
Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- SuperMark 1.5T EUDAMEDASM-030PIII(OPENMARK III) EUDAMEDASM-050P(OPENMARK 5000) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950743801072 EUDAMED06950743801034 EUDAMED06950743801065 EUDAMED
- Basic UDI-DI
- B-06950743801072 EUDAMED695074380100GX EUDAMEDB-06950743801065 EUDAMED
- Direct Marketing DI
- 06950743801034 EUDAMED
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMEDZ11050102 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Shenzhen Anke High-Tech Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06950743801072 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06950743801072 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Anke High-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016473
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 13ea268a-db7b-4d9e-8bc3-a3d443343862 61 fields · synced Aug 3, 2026
- EUDAMED 2a4441a7-dd37-43e0-a459-fdcf9db8723f 61 fields · synced May 18, 2026
- EUDAMED 0209cd27-682e-4d6c-937c-48d12168dc4c 61 fields · synced May 18, 2026