R-One Robotic Platform
by Robocath S.A.S France EUDAMED
Ref RBH01P0001, RBH01P0000
EMDN Z12059099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number3770024670RBH01P00004C | Date14 Mar 2023 | StatusActive |
| European Union | CE/MDR | Number3770024670RBH01P00004C | Date14 Mar 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Model / Reference
- RBH01P0001, RBH01P0000
- Primary DI / UDI-DI
- 03770024670134, D-RBH01P0000RK, 03770024670028
- Basic UDI-DI
- 3770024670RBH01P00004C, B-RBH01P0000RK
- Direct Marketing DI
- 0377002467013403770024670028
- EMDN Code
- Z12059099 Various instruments for cardiology and cardiac surgery -other
- Device Class
- Class IIb
- Market of Registration
- GermanyFrance
Manufacturer details
- EUDAMED SRN
- FR-MF-000003651
Other devices from Robocath S.A.S
Properties & raw data
Show properties, registry sources and raw records
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
Sources (3)
- EUDAMED e4cc9d4c-b7d5-488c-bd7c-b9ba6dd052a2
- EUDAMED D-RBH01P0000RK|B-RBH01P0000RK
- EUDAMED 03770024670028|3770024670RBH01P00004C