Identity
- Trade Name
- EPIONE RoboKit EUDAMEDFDA UDI
- Generic Name
- Surgical optical-tracking spatial marker, single-use FDA UDI
- Device Name
- EPIONE RoboKit EUDAMEDThe 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 tracked. FDA UDI
- Model / Reference
- 09-0057 EUDAMEDFDA UDI
- Description
- 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 tracked. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760305400260 EUDAMEDFDA UDI
- Basic UDI-DI
- 37603054003RKYD EUDAMED
- FDA Product Code
- LRO FDA UDI
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Surgical optical-tracking spatial marker, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- 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. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
EPIONE RoboKit by Quantum Surgical SAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37603054003RKYD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Quantum Surgical sas
- EUDAMED SRN
- FR-PR-000041795
Sources (2)
- EUDAMED cfdd572c-3334-4916-a66f-d30ef529d297 61 fields · synced Jun 19, 2026
- FDA UDI 3dd63a4d-ffef-46ce-a7c9-1e9e2650c3bd 33 fields · synced May 30, 2026