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Computed Tomography X-ray System
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 88000870Model uCT 960+Ref 88000228
Identity
- Device Name
- Computed Tomography X-ray System EUDAMED
- Model / Reference
- uCT 960+ EUDAMED88000870 EUDAMED88000228 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576831098 EUDAMED
- Basic UDI-DI
- 697157683109NB EUDAMEDB-06971576831098 EUDAMED
- EMDN Code
- Z11030607 COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE 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
Computed Tomography X-ray System by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172135 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 697157683109NB | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683109NB | 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 (3)
- EUDAMED f1607ce1-3ec4-4dbf-9649-5093ef5ad26e 61 fields · synced Oct 6, 2026
- EUDAMED 4c31013e-da0b-4219-9c2b-afa17500032b 61 fields · synced May 18, 2026
- FDA 510(k) K172135 1 fields · synced May 18, 2026