TRADE NAME ROBIN Robotic Unit
by Orthokey Italia SRL United States EUDAMED
Ref RX78
EMDN Z12020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805267596RoboticUnit77 | Date23 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Robin Robotic Unit
- Model / Reference
- RX78
- Primary DI / UDI-DI
- 08052675961034
- Basic UDI-DI
- 805267596RoboticUnit77
- EMDN Code
- Z12020101 Robot-assisted endoscopic surgery systems
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026488
Other devices from Orthokey Italia SRL
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 (1)
- EUDAMED 6a1e5262-728d-4ae8-848e-9c22a08187fe