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Positron Emission Tomography and Computed Tomography System
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 88000025Model uEXPLORER
Identity
- Trade Name
- uEXPLORER FDA UDI
- Generic Name
- PET/CT system FDA UDI
- Device Name
- Positron Emission Tomography and Computed Tomography System EUDAMEDFDA UDI
- Model / Reference
- uEXPLORER EUDAMEDFDA UDI88000025 EUDAMED
- Description
- Positron Emission Tomography and Computed Tomography System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576832040 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683204N6 EUDAMEDB-06971576832040 EUDAMED
- 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
- 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
Positron Emission Tomography and Computed Tomography System by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — FDA_510K, MDD, MDR — listed in…
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 | K231762 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 697157683204N6 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683204N6 | 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 d04cf466-e929-472b-9b10-19213cb6f4f3 61 fields · synced Oct 9, 2026
- EUDAMED 8860f752-fbc1-4d23-b4a6-350ea6443f81 61 fields · synced May 18, 2026
- FDA UDI 7a0ad3ee-2f90-4625-9b5a-82f9f181cf26 35 fields · synced May 30, 2026
- FDA 510(k) K231762 1 fields · synced May 18, 2026