Identity
- Trade Name
- uMI FDA UDI
- Generic Name
- PET/CT system FDA UDI
- Device Name
- Positron Emission Tomography and Computed Tomography System EUDAMEDFDA UDI
- Model / Reference
- uMI 550 EUDAMEDFDA UDI88000057 EUDAMED
- Description
- Positron Emission Tomography and Computed Tomography System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576832026 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971576832026 EUDAMED697157683202N2 EUDAMED
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
- GMDN Term
- PET/CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 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
No
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
88000057 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971576832026 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06971576832026 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 560c1fbf-4183-4cfe-a0d3-f5d7645748d0 61 fields · synced Oct 7, 2026
- FDA UDI 6cf7ceb2-9306-4af8-9f2d-190c1205ff15 35 fields · synced May 29, 2026
- EUDAMED 4dcde9da-3dcf-4907-bf53-e9d078359568 61 fields · synced Oct 6, 2026