Identity
- Trade Name
- GeniusSkin Handpiece EUDAMEDN/A FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Device Name
- Electrosurgical Unit EUDAMEDHANDPIECE ASSY_LUTRONIC GENIUS FDA UDI
- Model / Reference
- LUTRONIC GENIUS EUDAMEDHANDPIECE_LUTRONIC GENIUS FDA UDI
- Description
- HANDPIECE ASSY_LUTRONIC GENIUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809447652283 EUDAMEDFDA UDI
- Basic UDI-DI
- 88094476511007AVT EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Radio-frequency skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foot-switch, electrical
GeniusSkin Handpiece by Lutronic Corporation — Class IIb — 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 | 88094476511007AVT | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 bee1e0f8-2a31-4b1b-84cb-d4ecd2f31c16 61 fields · synced Jul 12, 2026
- FDA UDI 4778dd3f-cf8a-414c-b9a8-9a9ff8be9e65 35 fields · synced May 30, 2026