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 780 EUDAMEDFDA UDI80512213 EUDAMED
- Description
- Positron Emission Tomography and Computed Tomography System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576832033 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971576832033 EUDAMED697157683203N4 EUDAMED
- 510(k) Number
- K172143 FDA UDI
- FDA Product Code
- JAK FDA UDIKPS 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
- 892.1750 FDA UDI892.1200 FDA UDI
- Market of Registration
- Romania EUDAMEDPoland 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
80512213 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-06971576832033 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06971576832033 | 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 f9ed8d5f-b19a-4215-860b-52410377b446 61 fields · synced Oct 7, 2026
- EUDAMED 37b40790-18fc-4542-8f48-703aaed4dffe 61 fields · synced May 18, 2026
- FDA UDI d6b9a1fd-9a26-47b0-9d97-eac2e5766cd2 35 fields · synced May 30, 2026