Identity
- Model / Reference
- uMC 560i EUDAMED88000010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576833092 EUDAMED
- Basic UDI-DI
- 697157683309NM EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb 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
88000010 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K183144 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683309NM | Class IIb | 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 b261f49d-a933-4fb0-af06-2d9dcdf1067f 61 fields · synced Oct 6, 2026
- FDA 510(k) K183144 1 fields · synced May 18, 2026