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Computed Tomography X-ray System
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 88000817Model uCT 550Ref 88000043
Identity
- Trade Name
- uCT FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Computed Tomography X-ray System EUDAMEDFDA UDI
- Model / Reference
- uCT 550 EUDAMEDFDA UDI88000817 EUDAMED88000043 EUDAMED
- Description
- Computed Tomography X-ray System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576831036 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683103MX EUDAMEDB-06971576831036 EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030605 COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Computed Tomography X-ray System by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, 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 | K241166 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 697157683103MX | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683103MX | 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 (4)
- EUDAMED 83a4d54c-e820-499f-9aa7-7457bd31441e 61 fields · synced Oct 7, 2026
- EUDAMED a70d91ef-93a8-4557-ab14-44f652859e15 61 fields · synced May 17, 2026
- FDA UDI 70e93581-47eb-4644-81d6-2b7be6f1caae 34 fields · synced May 30, 2026
- FDA 510(k) K241166 1 fields · synced May 18, 2026