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Computed Tomography X-ray System
EUDAMEDClass IIb (EU MDR)
Ref 88000944Model uCT 868Ref 88001123Model uCT Orion Extra
Identity
- Device Name
- Computed Tomography X-ray System EUDAMED
- Model / Reference
- uCT 868 EUDAMED88000944 EUDAMEDuCT Orion Extra EUDAMED88001123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576831494 EUDAMED06971576831425 EUDAMED
- Basic UDI-DI
- 697157683149NP EUDAMED697157683142N9 EUDAMED
- EMDN Code
- Z11030607 COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE EUDAMEDZ11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS 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 — 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 | 697157683149NP | 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 9ff58b7f-aff6-44ff-a8fa-87ac7d9f85b5 61 fields · synced Oct 5, 2026
- EUDAMED b731e227-1fae-4ae7-a8fa-29e36f3d0860 61 fields · synced May 18, 2026