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Radiation therapy treatment planning system
EUDAMEDClass IIb (EU MDR)
Ref 88002057Model uTPS OmniplanTx
Identity
- Device Name
- Radiation therapy treatment planning system EUDAMED
- Model / Reference
- uTPS OmniplanTx EUDAMED88002057 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576835225 EUDAMED
- Basic UDI-DI
- 697157683522NP EUDAMED
- EMDN Code
- Z11010192 LINEAR ACCELERATORS - MEDICAL DEVICE SOFTWARE 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Radiation therapy treatment planning system by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697157683522NP | 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 ee590eee-4be9-4ffe-9b6e-b37abf203c2a 61 fields · synced Oct 6, 2026