← Back to catalogue
Magnetic Resonance Imaging System
EUDAMEDClass IIa (EU MDR)
Ref 88001215Model uMR 780
Identity
- Device Name
- Magnetic Resonance Imaging System EUDAMED
- Model / Reference
- uMR 780 EUDAMED88001215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576830442 EUDAMED
- Basic UDI-DI
- 697157683044N8 EUDAMED
- EMDN Code
- Z11050105 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Magnetic Resonance Imaging System by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697157683044N8 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 260ea89f-f27c-4d9c-a98b-ff41f3a95896 61 fields · synced Oct 8, 2026