Hadrontherapic System with Protons and/or Carbon Ions
by Fondazione Centro Nazionale Di Adroterapia Oncologica EUDAMED
Active
Ref CNAO-01
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCVP0006230225 | Date1 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CVP0006230225 Amended
Product verification EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 1 Apr 2025
- Expires
- 5 Apr 2028
- Reason
- Other
- CVT000223 Issued
Type examination EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 6 Apr 2023
- Expires
- 5 Apr 2028
Specification
- Device Name
- Hadrontherapic System with Protons and/or Carbon Ions
- Model / Reference
- CNAO-01
- Primary DI / UDI-DI
- 08054154660001
- Basic UDI-DI
- 805415466_CNAO-01_EP
- EMDN Code
- Z11019099 Various radiotherapy and radiosurgery instruments - other
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000021295
Other devices from Fondazione Centro Nazionale Di Adroterapia Oncologica
Properties
Show 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