Computed Tomography X-ray System
by Shanghai United Imaging Healthcare Co., Ltd. 6 variants
Ref 88002944Model uCT SiriuX Ultrix
Computed Tomography X-ray System (88002944) is a Class IIb device made by Shanghai United Imaging Healthcare Co., Ltd., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 697157683152NC), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697157683152NC 06971576831524 | Date1 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 697157683152NC
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Computed Tomography X-ray System
- Model / reference
- uCT SiriuX Ultrix, 88002944
- Primary DI / UDI-DI
- 06971576831524
- Basic UDI-DI
- 697157683152NC
- EMDN code
- Z11030607 Computed tomographs - 256 layers or more
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000008501
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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