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Positron Emission Tomography and Computed Tomography System
EUDAMEDClass IIb (EU MDR)
Ref 88002513 Model uMI Panvivo EX
Identity
- Device Name
- Positron Emission Tomography and Computed Tomography System EUDAMED
- Model / Reference
- uMI Panvivo EX EUDAMED88002513 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576832279 EUDAMED
- Basic UDI-DI
- 697157683227NJ EUDAMED
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Positron Emission Tomography and Computed Tomography System by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697157683227NJ | 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 (1)
- EUDAMED 410ec11e-2ea8-435f-a85f-fd2863a7ca9b 61 fields · synced Oct 7, 2026