Amadeo R-AX motorized
Ref AR4190Model Amadeo R motorised
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 | Number42508029AR41002G 04250802900312 | Date29 Jul 2024 | 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- Withdrawn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
- Amadeo R motorised, AR4190
- Primary DI / UDI-DI
- 04250802900312
- Basic UDI-DI
- 42508029AR41002G
- EMDN Code
- Z11039012 X-ray tube assembly
- Device Class
- Class IIb
- Medical Purpose
- The Amadeo R motorised is a partially motorised floor-mounted X-ray system for taking all diagnostic projection radiographs.
Manufacturer details
- EUDAMED SRN
- DE-PR-000037490
Other devices from Oehm Und Rehbein GmbH
Properties
Other properties (1)
- Sterile: No