Accela
by Varian Medical Systems, Inc.
Ref Accela 1.0
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number089947500200148Q4 00858086006962 | Date6 Nov 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- Withdrawn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
- Accela 1.0
- Primary DI / UDI-DI
- 00858086006962
- Basic UDI-DI
- 089947500200148Q4
- EMDN code
- Z11010103 Multi and high energy linear accelerators
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000001784
- Authorised representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Other devices from Varian Medical Systems, Inc.
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No