← Back to catalogue
Computed Tomography X-ray System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 88000855Model uCT 760Ref 80000063
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 760 EUDAMEDFDA UDI88000855 EUDAMED80000063 EUDAMED
- Description
- Computed Tomography X-ray System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576831043 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683104MZ EUDAMEDB-06971576831043 EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 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 — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697157683104MZ | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683104MZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 f0197550-3953-426e-a8ea-e32a86eeadaf 61 fields · synced Oct 7, 2026
- EUDAMED 5449899a-3ddc-4142-8d5e-15aee1d387b2 61 fields · synced May 18, 2026
- FDA UDI 935d45d4-5938-43de-b444-760650e9008e 35 fields · synced May 30, 2026