NeuRT Aurora radiotherapy system
by Neusoft IntelliRay Technology Co., Ltd.
Model NeuRT Aurora
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697662596000017A 06976625960057 | Date31 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- NeuRT Aurora
- Primary DI / UDI-DI
- 06976625960057
- Basic UDI-DI
- 697662596000017A
- EMDN Code
- Z11010101 Single energy linear accelerators
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000042023
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No