Identity
- Trade Name
- P16D EUDAMEDP16D BOX (10EA) EUDAMED
- Device Name
- Electrosurgical Unit EUDAMED
- Model / Reference
- LUTRONIC GENIUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800291820798 EUDAMED08800291820804 EUDAMED
- Basic UDI-DI
- 88002918211007AHA EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Foot-switch, electrical
P16d by Cynosure Lutronic Technology Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88002918211007AHA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Cynosure Lutronic Technology Corporation
- EUDAMED SRN
- KR-MF-000047499
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 09bd6588-b9fd-4f28-8b9a-be1ccbcbc268 61 fields · synced Jul 8, 2026
- EUDAMED cf5a5939-3b3e-45e1-ba90-cec5aafb24a4 61 fields · synced May 19, 2026
- EUDAMED bad4d1c5-7499-48cd-9afa-86af0c4ff76f 61 fields · synced Jul 8, 2026