Identity
- Device Name
- Electrosurgical Unit EUDAMED
- Model / Reference
- LUTRONIC GENIUS EUDAMEDINFINI EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-11007EE EUDAMEDD-11001E2 EUDAMED
- Basic UDI-DI
- B-11007EE EUDAMEDB-11001E2 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDLatvia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Foot-switch, electrical
Electrosurgical Unit by Lutronic Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-11007EE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
- EUDAMED SRN
- KR-MF-000009035
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4bd4a7bf-7feb-4c30-a527-9aaffe27d2f7 61 fields · synced Jul 9, 2026
- EUDAMED 38e78dc6-0da7-4120-a5f7-7a4895bdfc31 61 fields · synced May 18, 2026