Identity
- Model / Reference
- uWS-MR EUDAMED88000844 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576834075 EUDAMED
- Basic UDI-DI
- 697157683407NN EUDAMED
- EMDN Code
- Z11050192 MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
88000844 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192601 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K172999 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K183164 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697157683407NN | 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 (2)
- EUDAMED 349cb987-7723-4e82-80ed-cc8d4d495699 61 fields · synced Oct 6, 2026
- FDA 510(k) K192601 1 fields · synced May 18, 2026