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Medical Linear Accelerator System
EUDAMEDClass IIb (EU MDR)
Ref Class llbModel uRT-linac 506cModel uLinac EternaTx
Identity
- Device Name
- Medical Linear Accelerator System EUDAMED
- Model / Reference
- uRT-linac 506c EUDAMEDClass llb EUDAMEDuLinac EternaTx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576835010 EUDAMED06971576835126 EUDAMED
- Basic UDI-DI
- 697157683501NF EUDAMED697157683512NL EUDAMED
- Direct Marketing DI
- 06971576835010 EUDAMED06971576835126 EUDAMED
- EMDN Code
- Z11010101 SINGLE ENERGY LINEAR ACCELERATORS 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
Medical Linear Accelerator 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 | 697157683501NF | 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 (2)
- EUDAMED 2c48a635-b165-477e-84fa-678d25f766ca 61 fields · synced Oct 8, 2026
- EUDAMED 1ea428d8-b3a9-4fb4-8b57-b041c4ca8270 61 fields · synced May 19, 2026