Basic UDI-DI
Eu Mdr
Eu Md Class 1
EPIONE RoboKit
Code: 37603054003RKYD
Devices
1
Certificates
0
Notified Bodies
0
Auth. Representatives
0
Basic Information
- UDI-DI Code
- 37603054003RKYD
- Issuing Agency
- GS1
- Device Model
- 09-0057
- Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Last Updated
- January 14, 2025
Medical Purpose
The EPIONE RoboKit is used during the CT guided procedures performed with EPIONE. Sterile drapes are used to cover: • the robotic arm, • the touchscreen of the display cart, • the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments. The EPIONE RoboKit includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE RoboKit is not sterile.
Certificate Health
No certificates associated with this Basic UDI-DI.
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| EPIONE RoboKit | On the market |