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Magnetic Resonance Imaging System
EUDAMEDClass IIa (EU MDR)
Ref ASM-040PModel ASM-040P(OPENMARK 4000)
Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- ASM-040P(OPENMARK 4000) EUDAMEDASM-040P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950743801041 EUDAMED
- Basic UDI-DI
- B-06950743801041 EUDAMED
- EMDN Code
- Z11050102 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
- Italy 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 Anke High-Tech 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-06950743801041 | 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 (1)
- EUDAMED 10393773-25b4-4d39-9778-84338537518b 61 fields · synced Jun 19, 2026