Robin Navigation Unit Light
by Orthokey Italia SRL FDA registration: Italy EUDAMED
Ref 20000301Model Robin Navigation EMDN Z12011401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805267596Robin2U | Date9 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- IT348354 Issued
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 17 Dec 2025
- Expires
- 16 Dec 2030
Specification
- Model / Reference
- Robin Navigation, 20000301
- Primary DI / UDI-DI
- 08052675961027
- Basic UDI-DI
- 805267596Robin2U
- EMDN Code
- Z12011401 Surgical navigation system
- Device Class
- Class IIa
- 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 08052675961027|805267596ROBIN2U