Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- uMR 580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576830060 EUDAMED
- Basic UDI-DI
- 697157683006MY EUDAMED
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Category: Full-body MRI system, superconducting magnet
Magnetic Resonance Imaging System by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697157683006MY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000008501
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 99ff4ac4-ff5e-407d-9453-2a7baf700fae 61 fields · synced Jun 20, 2026