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EPIONE RoboKit Plus

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 09-0046Model 09-0057

by Quantum Surgical sas

Identity

Trade Name
EPIONE RoboKit Plus EUDAMEDFDA UDI
Generic Name
Surgical optical-tracking spatial marker, single-use FDA UDI
Device Name
EPIONE RoboKit EUDAMED
The EPIONE® RoboKit™ Plus 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. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile. FDA UDI
Model / Reference
09-0057 EUDAMED
09-0046 EUDAMEDFDA UDI
Description
The EPIONE® RoboKit™ Plus 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. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile. FDA UDI

Identifiers

Primary DI / UDI-DI
03760305400253 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 EUDAMED
Class 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 Plus by Quantum Surgical SAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quantum Surgical sas
EUDAMED SRN
FR-PR-000041795

Sources (2)

  • EUDAMED ae862796-a501-447e-9f22-52848b8ca58b 61 fields · synced Jul 25, 2026
  • FDA UDI 35b4693b-3b64-49bc-a226-f81b8eee3d00 33 fields · synced May 30, 2026